Cordis MX61260 Mynx Control Venous Vascular Closure Device Installation Guide

Installation Guide for Cordis models including: 6F, 12F, MX61260 Mynx Control Venous Vascular Closure Device, MX61260, Mynx Control Venous Vascular Closure Device, Venous Vascular Closure Device, Vascular Closure Device, Closure Device

P040044.S097.Mynx.Control.IFU.06-27-2024

Ankita Phophalia Cordis Corp.

File Info : application/pdf, 16 Pages, 906.25KB

P040044S097C

LBL10364.4 Instructions for Use MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F MX61260
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INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

English ....................................................................................................................................................................................................................................5

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

Explanation of symbols on labels and packaging:
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Do not re-use

Use-by date

Lot number

Sterilized using irradiation

Consult instructions for use or consult electronic instructions for use

Keep dry

Do not use if package is damaged and consult instructions for use

Upper limit of temperature

Catalogue number

Manufacturer

n units per box

Prohibition

Wait for two minutes

Do not re-sterilize

Caution

Keep away from sunlight

Non-Pyrogenic

10 ml LOCKING SYRINGE

Medical Device

Single sterile barrier system; Sterilized using irradiation

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

Figure 1: MYNX CONTROL VENOUS VCD 6F-12F

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

ENGLISH

STERILE. Sterilized with electron beam radiation. Nonpyrogenic. For one use only. Do not re-sterilize. Store in a cool, dark, dry place. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Instructions for Use The device brand name is the Cordis MYNX CONTROLTM VENOUS Vascular Closure Device (VCD) 6F-12F
To ensure proper deployment and use of this device and to prevent injury to patients, read all information contained in these instructions for use.

DEVICE DESCRIPTION
The MYNX CONTROL VENOUS VCD 6F-12F is designed to achieve femoral vein hemostasis via delivery of the GRIP TECHNOLOGYTM sealant, an extravascular, water-soluble synthetic hydrogel, using a balloon catheter in conjunction with a standard procedural sheath. The GRIP TECHNOLOGYTM sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the venotomy. The sealant is resorbed by the body within 30 days. The MYNX CONTROL VENOUS VCD 6F-12F sheath catch is designed to accommodate large Catheter Sheath Introducers up to 12F inner diameter.
The MYNX CONTROL VENOUS VCD 6F-12F is supplied with a 10 ml locking syringe used for balloon inflation and deflation.
The device contains no components manufactured from latex rubber. The catheter shaft has a silicone lubricant to facilitate insertion and withdrawal into compatible sheaths.
Refer to Figure 1 for the MYNX CONTROL VENOUS VCD 6F-12F components.

INTENDED PURPOSE The MYNX CONTROL VENOUS VCD 6F-12F is intended to achieve femoral vein hemostasis.

INDICATIONS FOR USE
The MYNX CONTROL VENOUS Vascular Closure Device (VCD) 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis, ambulation, and discharge eligibillityin patients who have undergone catheterbased procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.

PATIENT TARGET GROUP The patient target group includes individuals who have undergone catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs. The patient target group of this device is based on the patient's anatomy and compatibility with the device.

PERFORMANCE CHARACTERISTICS The MYNX CONTROL VENOUS VCD 6F-12F is designed to achieve femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The balloon catheter is designed to be introduced into the femoral introducer sheath and provide temporary hemostasis. The hydrogel sealant is housed next to the balloon and delivered in the extravascular space above the venotomy via actuation of a Button in the delivery system when an appropriate tension is applied on the balloon to achieve temporary hemostasis. Upon delivery, the hydrogel sealant expands by absorption of the body fluids to achieve hemostasis.

CONTRAINDICATIONS There are no known contraindications for the MYNX CONTROL VENOUS VCD 6F-12F.

WARNINGS Do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.
DO NOT REUSE OR RESTERILIZE. The MYNX CONTROL VENOUS VCD 6F-12F is for single use only. The catheter is loaded with a single Hydrogel sealant. Reuse of the device would result in no delivery of Hydrogel sealant. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture site is located above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a hematoma/bleed. Verify the location of the puncture site via imaging.
Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture is through the posterior wall as such punctures may result in a retroperitoneal hematoma/bleed.

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

SHEATH INTRODUCERS INCOMPATIBLE WITH MYNX CONTROL VENOUS VCD 6F-12F USE ONLY WITH A STANDARD SHEATH INTRODUCER with up to 12 cm effective length. Cordis test results have shown that the sheath introducer listed in Table 1 is incompatible with the MYNX CONTROL VENOUS VCD 6F-12F due the hemostatic valve design.
Table 1: Incompatible sheath introducer for all French sizes specific to the MYNX CONTROL VENOUS VCD 6F-12F range. The third-party trademarks used herein are trademarks of their respective owners.

MANUFACTURER Cook

DESCRIPTION Check-FloTM PerformerTM Introducer

The MYNX CONTROL VENOUS VCD 6F-12F should not be used if a < 6F or > 12F procedural sheath (inner diameter) is used at closure.

PRECAUTIONS The MYNX CONTROL VENOUS VCD 6F-12F should only be used by a trained licensed physician or healthcare professional.
The MYNX CONTROL VENOUS VCD 6F-12F should not be used in patients with a known allergy to PEG.
The safety and effectiveness of the lubricated device has not been established, or is unknown, in vascular regions other than those specifically indicated. Do not expose lubricated catheter shaft to organic solvents or antiseptic solutions. Avoid wiping of the lubricated catheter shaft. In case of resistance with sheath introducer, exercise caution in removing the device and exchange device for a new one. Failure to abide by the warnings in this labeling might result in damage to the device lubrication, which may necessitate intervention or result in serious adverse events.
Exposure to temperatures above 25°C (77°F) may damage the components.

SPECIAL PATIENT POPULATIONS The safety and effectiveness of the MYNX CONTROL VENOUS VCD 6F-12F have not been established in the following patient populations: · Pediatric patients or others with small common femoral veins (< 5 mm in diameter) · Patients with clinically significant peripheral vascular disease in the vicinity of the puncture · Patients with chronic use of systemic steroids · Patients with prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral vein · Patients with bleeding disorders such as thrombocytopenia (platelet count <100,000/mm3), hemophilia, von
Willebrand's disease or anemia (Hgb < 10 g/dL, Hct < 30%) · Patients with uncontrolled hypertension (systolic BP > 180 mm Hg) · Patients with morbid obesity (BMI > 45 or < 20kg/m2,) · Patients who are pregnant or lactating

POTENTIAL ADVERSE EVENTS Complications may occur and may be related to the procedure or the vascular closure device. They include, but are not limited to:

· Allergic reaction · Arterio-venous fistula · Bleeding from the access site · Bruising at the access site · Death · Deep vein thrombosis · Device failure/malfunction · Ecchymosis · Edema · Embolization (tissue, thrombus,
air, calcific debris, device)

· Hematoma · Infection · Inflammatory reaction · Intimal tear / dissection · Laceration of the vessel wall · Loss of lower extremity pulse · Lower extremity ischemia · Nerve injury · Oozing from the access site · Perforation of the vessel wall

· Pseudoaneurysm Pulmonary embolism
· Puncture site pain · Retroperitoneal bleeding · Superficial vein thrombosis · Vascular injury · Vascular occlusion · Vasovagal response · Venous thrombus · Wound dehiscence

For the specific adverse events that occurred during the ReliaSeal Clinical Trial, please see ReliaSeal Clinical Trial Results.

RELIASEAL CLINICAL TRIAL 6

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

MYNX CONTROL VENOUS VCD 6F-12F was evaluated for safety and effectiveness in a prospective, multi-center, randomized (2:1) clinical trial comparing MYNX CONTROL VENOUS VCD 6F-12F to manual compression (MC) in sealing femoral venous access sites in patients who have undergone catheter-based procedures utilizing one or more procedural sheaths up to 12F with single or multiple access sites in one or both limbs. The study enrolled a total of 314 subjects (44 roll-in and 270 randomized) across 13 U.S. sites. The study endpoint objectives were to demonstrate MYNX CONTROL VENOUS VCD 6F-12F non-inferiority safety (combined major venous access site closure- related complications through 30 days post procedure) and effectiveness superiority (Time to Ambulation (TTA) in hours and Time to Hemostasis (TTH) in minutes) compared to MC. The hypothesis for the primary safety endpoint was that the rate of CEC-adjudicated combined major venous access site closure-related complications through 30 days post-procedure for subjects treated with the Mynx CONTROL VENOUS VCD is non-inferior to the rate for subjects using manual compression. Subjects were followed for 30 days after the procedure. Seventy-two (72) subjects (47 MYNX CONTROL VENOUS VCD and 25 MC) were enrolled in a duplex ultrasound (DUS) sub study. These subjects had a DUS prior to discharge and, if any complications were noted at discharge, those subjects were required to undergo a DUS at their 30-day follow-up visit.

Patients were required to be 18 years of age, have signed the informed consent and have planned, elective, nonemergent catheter-based procedure(s) via the common femoral vein(s) using 6F 12F introducer sheaths with no contraindications for emergent vascular surgery or manual compression of the venous access sites. Pregnant women or women who were lactating or planned to be pregnant were excluded. Patients were excluded if they used systemic steroids (IV or oral) within 30 days, had a history of bleeding disorders, deep vein thrombosis (DVT), pulmonary embolism (PE), or thrombophlebitis within 6 months, had a platelet count < 100,000 cells/mm3, hemoglobin (Hgb) < 10 g/dl, hematocrit (Hct) < 30%, uncontrolled hypertension (HTN) with systolic BP > 180 mm Hg, or critical illness requiring blood pressure (BP) stabilization, serum creatinine > 2.5 mg/dL, body-mass index (BMI > 45 kg/m2 or < 20 kg/m2, any allergy to polyethylene glycol or contrast medium, active systemic infection or cutaneous infection or inflammation at the target access site, Covid-19 infection, positive test within 14 days or recent Covid-19 exposure, life expectancy < 30 days, would refuse a blood transfusion if needed. Patients were also excluded if they had previous vascular surgery or repair in the vicinity of the target access site within 90 days, recent (within 10 days) femoral arteriotomy or venotomy in either limb, use of VCD in either limb within 30 days, planned procedures involving femoral arterial or venous access in either limb within 30 days post procedure or prior to study exit including planned staged procedures or concomitant conditions/comorbidities that per investigator's judgement could extend ambulation attempts beyond 2-3 hours and/or require extended hospitalization or re-hospitalization, or were unable to walk at least 20 feet without assistance.

Exclusion criteria evaluated prior to randomization and related to the index procedure (defined as the endovascular procedure from time of first venous access to the removal of the final procedural or device sheath) included any attempt or inadvertent arterial access/puncture with hematoma, procedural complications that could interfere with routine recovery, ambulation or discharge eligibility times, discretionary physician preference for hemostasis approach, physician determination that the patient could not attempt protocol-required ambulation (subjects randomized to MYNX CONTROL VENOUS VCD 6F-12F were required to attempt ambulation within 2 2.5 hours from time of final VCD removal delay > 2.5 hours was a protocol deviation), venous access site location above the inguinal ligament, intra-procedural bleeding around sheath, suspected intraluminal thrombus, hematoma, pseudoaneurysm or AV fistula, difficult insertion of procedural sheath or needle stick problems (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.), or use of a < 6F or > 12F procedural sheath at any time during the procedure or at closure.

A total of 270 subjects were randomized, 177 to MYNX CONTROL VENOUS VCD 6F-12F and 93 to manual compression with even age distribution (mean 69 years of age) and a larger cohort of men than women (2:1) also evenly distributed in both randomized cohorts.

RELIASEAL CLINICAL TRIAL RESULTS
SAFETY RESULTS The 177 subjects randomized to MYNX CONTROL VENOUS VCD 6F-12F received 503 devices to close 470 access sites (236 limbs) all with technical device success and zero (0) major complications of the target limb(s) access sites within 30 days. Activated clotting time (ACT) was collected at the conclusion of the procedure with mean ACT for subjects reported as 315.4 ± 89.13 seconds and 326.9 ± 72.19 seconds in the MYNX CONTROL VENOUS VCD 6F-12F group (50/177) and MC group (24/93), respectively. There were no minor complications of the target limb access site within 30 days in the MYNX CONTROL VENOUS VCD 6F-12F group. Minor complications of the target limb access site within 30 days were reported in 5.0% (6 limbs) of the MC group. A clinical events committee (CEC) reviewed major and minor complications. The Major Complications and Minor Complications within 30 days, as adjudicated by the CEC, in all Randomized Subjects are listed in Tables 2 and 3, respectively.

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

Table 2: CEC Adjudicated Major Complications Directly Attributed to the VCD/Manual Compression within 30 days Intent to Treat (ITT) Subjects

Major Venous Access Site Closure-Related Complications at 30 Days by Event

MYNX CONTROL VENOUS VCD 6F-12F
(N=177 Subjects)

Manual Compression (N=93 Subjects)

Major Complications of the Target Limb Access Site

within 30 Days

Access site-related bleeding requiring

transfusion, surgical intervention, or

rehospitalization

0.0%* 0.0%

0.8%*

0.8%

Vascular injury requiring surgical repair

0.0%

Access site-related infection

0.0%

Access site-related nerve injury

0.0%

Pulmonary embolism *Results calculated on a per limb basis

0.0%

Table 3: CEC Adjudicated Minor Complications Directly Attributed to the VCD/Manual Compression within 30 days Intent to Treat (ITT) Subjects

Minor Venous Access Site Closure-Related Complications at 30 Days by Event

MYNX CONTROL VENOUS VCD 6F-12F
(N=177 Subjects)

Manual Compression (N=93 Subjects)

Minor Complications of the Target Limb Access Site

within 30 Days

Pseudoaneurysm - Treated with thrombin

injection, fibrin adhesive injection, or

ultrasound guided compression and

documented by ultrasound

Pseudoaneurysm - Not requiring

treatment

AV Fistula

Access site related Hematoma > 6 cm documented by ultrasound

Access site-related bleeding requiring >

30 min to achieve hemostasis

Late access site-related bleeding

(following hospital discharge eligibility)

Transient loss of ipsilateral lower extremity pulse

Ipsilateral deep vein thrombosis documented by ultrasound

Transient access site-related nerve injury

Access site-related vessel laceration

Access site wound dehiscence

Local access site infection confirmed by

culture and sensitivity, treated with

intramuscular or oral antibiotics - Minor

Local access site inflammatory reaction Minor

Allergic reaction

Ecchymosis

*Results calculated on a per limb basis

0.0%*

0.0%

5.0%*
0.0%
0.8% 0.0% 0.8% 0.8% 1.7% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.8%

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

EFFECTIVENESS RESULTS Time to Ambulation (TTA) in the MYNX CONTROL VENOUS VCD 6F-12F group was significantly less than in the MC group, with a mean of 2.6 ± 1.03 hours vs. 5.1 ± 4.35 hours, respectively (p < 0.001). In addition, Time to Hemostasis (TTH) (analyzed per access site) was significantly reduced in the MYNX CONTROL VENOUS VCD 6F-12F subjects compared to the MC (2.1 ± 1.79 minutes vs. 11.4 ± 7.19 minutes, respectively); p < 0.001 demonstrating superiority of the MYNX CONTROL VENOUS VCD 6F-12F over MC for TTA and TTH statistically. Subjects treated with the MYNX CONTROL VENOUS VCD 6F-12F also showed a statistically significant shorter Time to Discharge Eligibility (TTDE/Secondary Effectiveness) compared to subjects treated with MC (3.1 ± 1.24 vs. 5.5 ± 4.58 hours, respectively); p < 0.001. The results of the primary endpoints are presented in Table 4 and the results of the secondary effectiveness endpoints are presented in Tables 5a and 5b.

Table 4: Primary Effectiveness Results (TTA and TTH) Intent to Treat (ITT) Subjects

MYNX CONTROL VENOUS VCD 6F-12F
(N=177 Subjects)

Manual Compression
(N=93 Subjects)

P-Value

Time to Ambulation (hr)

N (number of subjects)

172

Mean ± SD Median (IQR) Min, Max

2.6 ± 1.03 2.28 (2.08 - 3.08)
(0.83 6.42)

5.1 ± 4.35 3.90 (2.97 -
5.15) (1.15 31.17)

p<0.001

Time to Hemostasis (min)

N (number of access sites)

470

249

Mean ± SD

2.1 ± 1.79

11.4 ± 7.19

p<0.001

Median (IQR)

2 (1 - 3)

10 (6 - 15)

Min, Max

(0 - 19)

(0 - 37)

Table 5a: Secondary Effectiveness Results (TTDE) Intent to Treat (ITT) Subjects

MYNX CONTROL

Manual

VENOUS VCD 6F-12F

Compression

P-Value

(N=177 Subjects)

(N=93 Subjects)

Time to Discharge Eligibility (hr)

N (number of subjects)

173

Mean ± SD Median (IQR)

3.1 ± 1.24 2.67 (2.35 - 3.52)

5.5 ± 4.58 4.25 (3.12 - 5.67)

p<0.001

Min, Max

(0.83 - 8.05)

(1.15 - 31.17)

Table 5b: Secondary Effectiveness Results (Procedural and Device Success) Intent to Treat (ITT) Subjects

MYNX CONTROL VENOUS VCD 6F-12F
(N=177 Subjects)

Manual Compression (N=93 Subjects)

Procedural Success

N (number of subjects)

100% (171/171)

98.9% (89/90)

Device Success

N (number of access sites)

100% (470/470)

N/A

CLINICAL BENEFITS Reliable closure of femoral vein access sites
CONCLUSIONS The results from the ReliaSeal Trial demonstrate that patients who underwent catheter-based procedures utilizing 6F 12F procedural sheaths, with single or multiple access sites in one or both limbs, and who were treated with the MYNX CONTROL VENOUS VCD 6F-12F have had statistically and clinically significant decreased time to ambulation and time
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INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

to discharge eligibility when compared to patients treated with manual compression. Additionally, time to hemostasis for

MYNX CONTROL VENOUS VCD 6F-12F were superior compared to manual compression.

In addition, the trial demonstrated that the rates of total combined major complications were non-inferior for the MYNX CONTROL VENOUS VCD 6F-12F (0.0%) compared to manual compression (0.8%) patients. The rates of total combined minor complications were lower for MYNX CONTROL VENOUS VCD 6F-12F (0.0%) compared to manual compression (5.0%) patients.

Also, the MYNX CONTROL VENOUS VCD 6F-12F arm demonstrated a high procedural success rate (100%) and a high device success rate (100%).

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

PROCEDURE AND DEVICE PREPARATION

The techniques and procedures described in these Instructions for Use do not represent all medically acceptable protocols, nor are they intended as a substitute for the physician's experience and judgment in treating any specific patient.

HOW SUPPLIED The MYNX CONTROL VENOUS VCD 6F-12F is supplied sterile.
WARNING: Do not use if the MYNX CONTROL VENOUS VCD 6F-12F components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened. WARNING: DO NOT REUSE OR RESTERILIZE. The MYNX CONTROL VENOUS VCD 6F-12F is for single use only.
The MYNX CONTROL VENOUS VCD 6F-12F includes (Figure 1): (1) MYNX CONTROL VENOUS VCD 6F-12F including balloon catheter and integrated sealant (1) 10 ml locking syringe.
Also, included in the packaging: One (1) patient brochure for each device.

PROCEDURE PREPARATION
When using the MYNX CONTROL VENOUS VCD 6F-12F confirm that the procedural sheath is 6F to 12F inner diameter with effective working length not exceeding 12 cm.

WARNING: USE ONLY WITH A STANDARD SHEATH INTRODUCER with up to 12 cm effective length. WARNING: Do not use MYNX CONTROL VENOUS VCD 6F-12F if a < 6F or > 12F inner diameter procedural sheath is used at closure. WARNING: The MYNX CONTROL VENOUS VCD 6F-12F is not compatible with Cook Check-FloTM PerformerTM Introducer
PRECAUTION: The MYNX CONTROL VENOUS VCD 6F-12F should not be used in patients with a known allergy to polyethylene glycol (PEG).
NOTE: · If a patient has had a procedural sheath left in place for an extended period of time, consideration should be given
to the use of prophylactic antibiotics before inserting the MYNX CONTROL VENOUS VCD 6F-12F. · If the puncture is at or below the femoral bifurcation, the balloon may be prepped with a diluted contrast solution
(50% contrast / 50% saline), in place of 100% saline in order to visualize the balloon while pulling back to the venotomy and to ensure that the balloon properly abuts the venotomy. · Do not use 100% contrast solution as this will impact balloon inflation / deflation. Confirm via imaging prior to using the MYNX CONTROL VENOUS VCD 6F-12F: · Common femoral vein without posterior wall puncture. · Evidence of adequate flow. · No evidence of significant PVD in the vicinity of the puncture.
WARNING: Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture site is located above the inguinal ligament based upon bony landmarks. WARNING: Do not use MYNX CONTROL VENOUS VCD 6F-12F if the puncture is through the posterior wall
DEVICE PREPARATION AND POSITIONING · Flush the procedural sheath with sterile heparinized saline. PRECAUTION: Do not expose lubricated catheter shaft to organic solvents or antiseptic solutions. · Remove device components from packaging · Prepare balloon
Fill locking syringe with 2 to 3 ml of sterile saline (or a 50/50 saline/contrast mixture if fluoroscopy will be used to confirm balloon positioning), attach to stopcock and draw vacuum. Check Luer connector and tighten if necessary.
Inflate the balloon until the inflation indicator on the back of the device handle extends so that the entire black marker is fully visible with white border on either side. Check for leaks in the balloon and syringe connector; retighten if necessary. Discard the device if the balloon does not maintain pressure. Check for air bubbles in the balloon. If air bubbles are visible, deflate the balloon and draw vacuum with the syringe to remove bubbles. Re-inflate and re-check the balloon to ensure no air bubbles are present.
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INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

Deflate the balloon and leave syringe at neutral. Do not lock. (Figure 2)

Figure 2: Deflate Balloon and Leave Syringe at Neutral

PROCEDURAL STEPS
STEP 1: POSITION BALLOON
· Carefully hold and insert the atraumatic catheter tip of the MYNX CONTROL VENOUS VCD 6F-12F through the sheath valve. Align the device to the relative angle of the procedural sheath and carefully advance the catheter until the sheath catch is adjacent to the hub of the sheath. Rotate the sheath catch as needed to hook onto the sideport of the procedural sheath. (Figure 3a)
Figure 3a: Connect Device to Sheath

· Orient the device such that the tension indicator window on the handle assembly is clearly visible to the user.

· Inflate the balloon until the inflation indicator on the back of the device handle extends so that the entire black marker is fully visible with white border on either side and close stopcock. (Figure 3b and 3c)

Figure 3b: Inflate Balloon

Figure 3c: Close Stopcock

· Align the device with the tissue tract. Pull gently to retract the device and procedural sheath until the black line in the tension indicator window aligns with the marks on both sides of the white handle. This indicates that the balloon is abutting the venotomy and that the device is positioned to appropriately deliver the sealant extravascular to the venotomy. (Figure 4) Figure 4: Tension Indicator
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INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

STEP 2: DEPLOY SEALANT · While maintaining tension alignment of the markings, firmly press button #1 until it is fully depressed. The clock
symbol will become visible in the tension indicator window. This deploys and compresses the sealant against the venotomy for effective adhesion. (Figure 5a) Figure 5a: Deploy Sealant
· Lay the device down for 2 minutes, allowing the sealant to actively absorb body fluid and swell within the tissue tract. (Figure 5b) Figure 5b: Lay Device Down for 2 Minutes
STEP 3: REMOVE DEVICE · Fully retract the syringe plunger to lock position in order to draw vacuum. (Figure 6)
Figure 6: Lock Syringe Plunger
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INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

· Apply light fingertip compression proximal to the insertion site and then lightly grasp. the device at skin with thumb and forefinger to stabilize and realign with the tissue tract. (Figure 7a) Figure 7a: Compress and Stabilize
· Open the stopcock to deflate the balloon. (Figure 7b) Figure 7b: Deflate Balloon
To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.
· Pick up the device handle and realign with the tissue tract. Fully depress button #2 to retract the deflated balloon into the device catheter. (Figure 7c) Figure 7c: Retract Balloon 14

INSTRUCTIONS FOR USE MYNX CONTROLTM VENOUS Vascular Closure Device 6F-12F

· While maintaining fingertip compression on the skin, remove the device with procedural sheath from the patient. · Continue to apply fingertip compression for up to 1 minute or as needed. (Figure 8)
Figure 8: Apply Fingertip Compression

· Apply a sterile dressing once hemostasis is achieved. It is recommended that the patient follow physician orders regarding patient ambulation and discharge. Refer to Patient Brochure for post-care instructions. After use, all components used, and packaging materials may be a potential biohazard. Handle and dispose of in accordance with the accepted medical practice and with applicable local, state, and federal laws and regulations. DEVICE RELATED ADVERSE EVENT REPORTING Any adverse event (clinical incident) involving the Cordis MYNX CONTROL VENOUS VCD 6F-12F should be reported to Cordis immediately. To report an incident in the U.S.A., call the Product Quality Services Department at 1-800-327-7714.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE CORDIS PRODUCT(S) DESCRIBED IN THIS PUBLICATION. UNDER NO CIRCUMSTANCES SHALL CORDIS BE LIABLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND CORDIS TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH HEREIN. Descriptions or specifications in Cordis printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties. Cordis will not be responsible for any direct, incidental, or consequential damages resulting from reuse of the product.
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Cordis US Corp. 14201 North West 60th Avenue, Miami Lakes, Florida 33014, USA
1-800-327-7714 (U.S.A.) www.cordislabeling.com

Patents: www.cordis.com/na/patents

June 2024

LBL10364.4

©2024 Cordis. All Rights Reserved. Cordis, Cordis LOGO, GRIP TECHNOLOGY and MYNX CONTROL are trademarks of Cordis and may be registered in the US and/or in other countries. All other marks are the
property of their respective owners.
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References

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