Spectranetics Quick-Cross Support Catheter

Instructions for Use

1. Description

The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in 9 models. All models feature 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer connector is placed on the proximal end of each model. The distal 40 cm of each catheter model is coated with a lubricious, hydrophilic coating.

Model numbers 518-032 and 518-065 have a shaft of varying stiffness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 2.0 Fr and are compatible with a 0.014 inch or smaller guidewire.

Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiffness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.3 Fr and are compatible with a 0.018 inch or smaller guidewire.

Model numbers 518-036, 518-037, 518-038, and 518-066 have a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.8 Fr and are compatible with a 0.035 inch or smaller guidewire.

2. Indications for Use

The Spectranetics Quick-Cross Support Catheters are guidewire exchange and infusion devices designed for use in the vascular system. The catheters are intended to support a guidewire during access of vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

3. Specifications

Model	GW Compatibility, inch	Working Length, cm	Minimum Guidewire Length, cm	Distal Marker Spacing, mm	Outer Diameter (O.D.), inch	Distal Shaft Diameter, inch	Tip Profile, inch	Minimum Guide Catheter, Fr.	Sheath Compatibility, Fr.
518-032	0.014	135	180	15	0.039	0.026	0.020	5	4
518-065	0.014	150	180	15	0.039	0.026	0.020	5	4
518-033	0.018	90	150	15	0.044	0.030	0.023	5	4
518-034	0.018	135	180	15	0.044	0.030	0.023	5	4
518-035	0.018	150	180	15	0.044	0.030	0.023	5	4
518-066	0.035	65	150	50	0.063	0.050	0.041	6	5
518-036	0.035	90	150	50	0.063	0.050	0.041	6	5
518-037	0.035	135	180	50	0.063	0.050	0.041	6	5
518-038	0.035	150	180	50	0.063	0.050	0.041	6	5

4. Contraindications

No known contraindications.

5. Warnings

This catheter should only be used by physicians qualified to perform percutaneous, vascular interventions.
Catheter manipulation should only occur under fluoroscopy.
The catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.
The catheter should not be advanced into a vessel having a diameter smaller than the catheter outer diameter.

6. Precautions

DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination due to inappropriate reprocessing. Reuse of this single-use device could lead to serious patient injury or death and voids manufacturer warranties.
Maximum infusion pressure is 300 psi.
The catheter is designed and intended for intravascular use only.
This catheter is designed and intended for one-time use only.
Careful inspection before use should verify that the catheter has not been damaged in shipment and that its condition is suitable for the procedure.
Only use guidewires of the recommended diameter and length.
If the catheter is used for infusion, reference the table of flow rates and ensure infusion pressure does not exceed the recommendations.
Avoid introducing air or any other gas through the catheter into the vascular system.

7. Adverse Events

Vascular catheterization and/or vascular interventions may result in complications including but not limited to:

Vessel dissection, perforation, rupture or total occlusion
Unstable angina
Embolism
Hypo/hypertension
Acute myocardial infarction
Arrhythmia, including ventricular fibrillation
Death

8. How Supplied

This device has been sterilized using Radiation and is supplied STERILE. The devices are designated and designed for SINGLE USE ONLY and must not be resterilized and/or reused.

8.1 Sterilization

The sterility of the product is guaranteed only if the package is unopened and undamaged. Before use, visually inspect the sterile package to ensure that the seals have not been broken. Do not use the catheter if the integrity of the package has been compromised. Do not use catheter if its "Use Before Date," found on package labeling, has been passed.

8.2 Transportation and Storage

Keep dry. Store in a cool, dry place. Protect from direct sunlight and high temperature (greater than 60°C or 140°F).

8.3 Inspection Prior to Use

Before use, examine carefully for defects, all of the equipment to be used. Do not use any equipment if it is damaged or unintentionally opened.

9. Compatibility

See the table in Specifications. After use, dispose of all equipment in accordance with applicable specific requirements relating to hospital waste, and potentially bio-hazardous materials.

10. Directions for Use

Procedure Set-Up

Follow the "Directions for Use" section below.

Note: Follow instructions for use for all equipment to be used with the Quick-Cross Support catheters. For example, guiding catheters, introducer sheaths, and guidewires.

Preparation: Using sterile technique, open the sterile package. Gently remove the protective hoop with the catheter from the pouch. Fill a sterile standard luer-lock syringe with sterile saline. Before removing the catheter from the hoop, connect the syringe to the catheter proximal luer fitting, flush the catheter and allow the saline to fill the hoop. Set catheter in hoop aside until ready for use.
Insertion: Through a previously inserted, appropriately sized guiding catheter or introducer sheath, introduce the catheter over an appropriate sized guidewire (see specifications) using standard technique.
Advancement: Use fluoroscopic guidance when advancing the catheter to the desired location within the vasculature.
Removal: Gently withdraw the catheter using standard technique, being careful to maintain guidewire position if the guidewire is to remain in place.
Infusion: To perform infusion, withdraw the guidewire and reference the chart below. Note: Do not exceed 300 psi inlet infusion pressure.

Quick-Cross Infusion Flow Rates (ml/second) at 150 and 300 psi Injection Pressures for Saline and Contrast Solutions

Model	Size	Length	Sterile Saline		Contrast*
			150 psi	300 psi	150 psi	300 psi
518-032	0.014	135	1.1	1.6	0.4	1.0
518-065	0.014	150	1.0	1.5	0.4	0.7
518-033	0.018	90	2.0	2.9	0.8	1.6
518-034	0.018	135	1.8	2.5	0.7	1.2
518-035	0.018	150	1.7	2.4	0.6	1.2
518-066	0.035	65	8.7	12.4	5.8	10.4
518-036	0.035	90	6.8	10.0	4.2	7.2
518-037	0.035	135	4.7	7.8	3.4	6.1
518-038	0.035	150	5.4	8.0	3.2	5.5

* 75/25 Optiray 320 contrast / Sterile Saline mix

11. Warranty Information

Manufacturer's Limited Warranty

Manufacturer warrants that the Quick-Cross catheter is free from defects in material and workmanship when used by the stated "Use By" date and when package is unopened and undamaged immediately before use. Manufacturer's liability under this warranty is limited to replacement or refund of the purchase price of any defective Quick-Cross catheter. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the Quick-Cross catheter. Damage to the Quick-Cross catheter caused by misuse, alteration, improper storage or handling, or any other failure to follow these Instructions for Use will void this limited warranty. THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No person or entity, including any authorized representative or reseller of Manufacturer, has the authority to extend or expand this limited warranty and any purported attempt to do so will not be enforceable against Manufacturer.

12. Non-Standard Symbols

Importer

GW Compatibility: [Guidewire Compatibility Symbol]

Distal Marker Spacing: [Distal Marker Spacing Symbol]

Outer Diameter (O.D.): [Outer Diameter Symbol]

Tip Profile: [Tip Profile Symbol]

Sheath Compatibility: [Sheath Compatibility Symbol]

Working Length: [Working Length Symbol]

Manufacturer: [Manufacturer Symbol]

Authorized Representative in the European Community: [EC REP Symbol]

13. Applicable Standards

The standards identified in Table 13.1 were applied to the development of the device.

Standard/Norm and Date	Title
Biocompatibility: ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation of testing
Clinical Study: EN ISO 14155	Clinical Investigation of medical devices for human subjects
Design: EN ISO 10555-1 US 21 CFR 820	Sterile, single-use intravascular catheters - Part 1: General requirements Quality System Regulation
Environmental: ISO 14644-1 ISO 14644-2	Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness. Cleanrooms and associated controlled environments - Part 2: Specification for testing and monitoring to prove continued compliance with ISO 14644-1.
Labeling: EN 556-1 EN 980 EN 1041 ISO 15223	Sterilization of Medical Devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. Graphical symbols for use in labeling of Medical Devices. Information supplied by the manufacturer with medical devices Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
Packaging: EN ISO 11607-1 EN ISO 11607-2 ISO 780	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Packaging - Pictorial marking for handling of goods
Quality: EN ISO 13485	Medical devices -- Quality management systems
Risk Management: EN ISO 14971 EN 62366	Medical Devices - Application of risk management to medical devices Medical Devices - Application of usability engineering to medical devices
Sterilization: EN ISO 11137-1	Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

14. Disposal

Use and disposal must be in accordance with generally accepted medical practice and applicable local, state, and federal laws and regulations. Products may pose a potential biohazard after use.

If the packaging is damaged and / or the expiration date expires, the product is to be disposed of in accordance with the rules for the treatment of medical waste class A according to SanPiN 2.1.7.2790-10.

The used product is disposed of in accordance with the rules for the management of medical waste class B according to SanPiN 2.1.7.2790-10.