Essential Prescribing Information
The Cordis VISTA BRITE TIP® Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary of peripheral vascular systems.
- Discard after one procedure.
- Do not use with Ethiodol* or Lipiodol* contrast media or other contrast media that incorporates the components of these agents.
- Do not expose to organic solvents.
- If strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding. If the cause of the resistance cannot be determined, withdraw the catheter.
- Torquing the guiding catheter excessively while kinked may cause damage that could result in possible separation along the catheter shaft. Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer).
- Advancement, manipulation and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.
- Avoid damage to the vasculature through which the guiding catheter passes. The guiding catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
- Large internal lumen guiding catheters require less force on a syringe during injection.
- Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with complications.
- Adverse events may occur during or after procedure.
- Possible adverse events include, but are not limited to:
- Air embolism
- Hematoma at the puncture site
- Perforation of the heart or vessel wall
Prior to use, refer to the “Instruction for Use” supplied with these devices for indications, contraindications, adverse events, suggested procedure, warnings and precautions.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
*The third-party trademarks used herein are trademarks of their respective owners.