Quick-Cross PTCA Support Catheter Instruction Manual

Quick-Cross PTCA Support Catheter

Instructions for Use – Sections by Language

DESCRIPTION

The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in 9 models. All models have 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 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 number 518-032 and 518-065 has a shaft of varying stiff ness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 2.0 Fr and is compatible with a 0.014 inch or smaller guidewire.
Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiff ness 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 stiff ness 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.

INDICATIONS FOR USE

The Spectranetics Quick-Cross Support Catheters are guide wire 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.

SPECIFICATIONS

 | 518- 03| 518- 06| 518- 03| 518- 034| 518- 03| 518- 066| 518- 036| 518- 03| 518- 038
---|---|---|---|---|---|---|---|---|---
GW Compatibility, inch| 0.014| 0.014| 0.018| 0.018| 0.018| 0.03| 0.03| 0.03| 0.03
Working Length, cm| 3| 50| 90| 3| 50| 6| 90| 3| 50
Minimum guidewire length, cm| 80| 80| 50| 80| 80| 50| 50| 80| 80
Distal marker spacing, mm|  |  |  |  |  | 50| 50| 50| 50
Outer Diameter (O.D.), inch| 0.039| 0.039| 0.044| 0.044| 0.044| 0.06| 0.06| 0.06| 0.06
Distal Shaft diameter, inch| 0.026| 0.026| 0.030| 0.030| 0.030| 0.050| 0.050| 0.050| 0.050
Tip Pro le, inch| 0.020| 0.020| 0.02| 0.02| 0.02| 0.04| 0.04| 0.04| 0.04
Minimum Guide Catheter, Fr.|  |  |  |  |  |  |  |  |
Sheath Compatibility, Fr.| 4| 4| 4| 4| 4|  |  |  |

CONTRAINDICATIONS

No known contraindications

WARNINGS

• This catheter should only be used by physicians qualifi ed to perform percutaneous, vascular interventions.
• Catheter manipulation should only occur under fl uoroscopy.
• The catheter should not be advanced through an area of resistance unless the source of resistance is identifi ed by fl uoroscopy 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.

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 fl ow rates and ensure infusion pressure does not exceed the recommendations.
• Avoid introducing air or any other gas through the catheter into the vascular system.

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 fi brillation
• Death

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.

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.

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).

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.

COMPATIBILITY

• See the table in Specifi cations.
• After use, dispose of all equipment in accordance with applicable specifi c requirements relating to hospital waste, and potentially bio-hazardous materials.

DIRECTIONS FOR USE

Procedure Set-Up

1. 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.

2. 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 fi tting, fl ush the catheter and allow the saline to fi ll the hoop. Set catheter in hoop aside until ready for use.

3.  Insertion: Through a previously inserted, appropriately sized guiding catheter or introducer sheath, introduce the catheter over an appropriate sized guidewire (see specifi cations) using standard technique.

4. Advancement: Use fl uoroscopic guidance when advancing the catheter to the desired location within the vasculature.

5. Removal: Gently withdraw the catheter using standard technique, being careful to maintain guidewire position if the guidewire is to remain in place.

6. 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

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.

NON-STANDARD SYMBOLS

APPLICABLE STANDARDS

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

Table 13.1: Standards applied to the development of the Quick-Cross

Biocompatibility:
SO 10993-| Biological evaluation of medical devices – Part 1: Evaluation of testing
Clinical Study:
N ISO 14155| Clinical Investigation of medical devices for human subjects
Design:
N ISO 10555-| Sterile, single-use intravascular catheters – Part 1: General requirements
US 21 CFR 820| Quality System Regulation
Environmental:
SO 14644-| Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness.
SO 14644-2| Cleanrooms and associated controlled environments – Part 2: Specification for testing and monitoring to prove continued compliance with ISO 14644-1.
Labeling:
N 556-| Sterilization of Medical Devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices
N 980| Graphical symbols for use in labeling of Medical Devices.
N 104| Information supplied by the manufacturer with medical devices
SO 15223| Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
Packaging:
N ISO 11607-1| Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packag- ing systems
N ISO 11607-2| Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
SO 780| Packaging – Pictorial marking for handling of goods
Quality:
N ISO 13485| Medical devices — Quality management systems
Risk Management:
N ISO 1497| Medical Devices – Application of risk management to medical devices
N 62366| Medical Devices – Application of usability engineering to medical devices
Sterilization:
N ISO 11137-| Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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.

• Spectranetics Corporation
• 9965 Federal Drive, Colorado Springs, CO 80921 USA Tel: 1-800-231-0978 • Fax: 719-447-2022
• Authorized Russian Representative:
• 13, Sergey Makeev Str., Moscow, 123022, Russia PHILIPS Limited Liability Company
• [email protected]
• www.spectranetics.com

Contacts of the Attorney:
(Tel: (495) 937 93 00 Fax: (495) 937-93-07)

References

• Spectranetics | Philips

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