The guiding catheter is intended for use forintravascular introduction of interventional/diagnostic devices into the coronary or peripheralvascular systems.
None known for guiding catheters.
Risk of reuse: This product is designed and intended for single use. It is not designed to undergo reprocessing and re-sterilization after initial use. 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 with Ethiodol™ or Lipiodol™ contrast media, or other such contrast media which incorporates the components of these agents.
- Store in a cool, dark, dry place.
- Do not use open or damaged packages.
- Use prior to the “Use By” date.
- Do not resterilize.
- Do not expose to organic solvents.
- Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.
- 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 can not be determined, withdraw the catheter.
- Torquing the guiding catheter excessively while kinked may cause damage which 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.
- Extreme care must be taken to 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 the syringe during injection.
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at anytime during or after the procedure. Possible complications include, but are not limited to the following:
- air embolism
- hematoma at the puncture site
- perforation of the heart
- vessel damage, dissection or perforation
- reaction to contrast media