Indications, Safety, and Warnings
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
- For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.
- Do not use if package is opened or damaged.
- Due to the size and relative stiffness of the guiding catheters, extreme care must be taken to avoid damage to the wall of the vessels through which this catheter passes.
- Due to the size of the non-tapered tip, this catheter may occlude smaller vessels. Care must be taken not to completely block flow.
- When there is limited clearance between devices and the guide catheter lumen, devices must be advanced and withdrawn slowly with the valve open to reduce the risk of embolism.
- Use catheters prior to the expiration date specified on the package.
- The large internal diameter of the catheter permits injection with little force being required on the syringe. Inject slowly whenever attempting to opacify the vessels via this catheter.
- Guiding Catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure.
- This device has been delivered STERILE. Careful inspection prior to use should verify the size, shape, and condition of the catheter as suitable for the specific procedure.
- Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
- If resistance is encountered at any time during the insertion of the interventional device through the lumen of the guiding catheter, do not force passage. Determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, remove the entire dilatation system.
- If the guide catheter is torqued when kinked it may cause damage that could result in separation along the catheter shaft. In the event the catheter shaft becomes kinked, withdraw the guide catheter, guide wire, and catheter sheath introducer.
- After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
Use of Guiding Catheters may give rise to the following complications:
- Hemorrhage or Hematoma
- Allergic reaction to contrast medium
- Vessel or heart dissection, perforation
- Vessel spasm
- Myocardial infarction
- Vascular occlusion
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
The curve recommendations in this guide are not meant to replace patient-specific clinical judgment.