Indications, Safety, and Warnings
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions..
INTENDED USE / INDICATIONS FOR USE
TRAPPER Exchange Device is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. Trapper exchange Device is not intended for use outside of the guide catheter.
- None known.
- Do not use air or any gaseous medium to inflate the balloon.
- Do not advance Trapper Exchange Device beyond the distal tip of the guide catheter.
- Do not exceed the balloon rated burst pressure (20atm).
- Use of a pressure monitoring device is recommended to ensure adequate pressurization and to prevent over pressurization.
- Trapper Exchange Device has not been tested with more than one interventional device simultaneously in the guide catheter.
- Exercise care during handling of Trapper Exchange Device to reduce the possibility of accidental breakage, bending or kinking of the device shaft.
Potential adverse events (in alphabetical order) that may be associated with the use of an Exchange Device include, but are not limited to, the following:
- Abrupt closure
- Acute myocardial infarction
- Angina or unstable angina
- Arrhythmia, including ventricular fibrillation
- Coronary vessel dissection, perforation, rupture or injury
- Drug reactions, allergic reaction to contrast medium
- Minor vessel trauma
- Myocardial ischemia
- Pyrogenic reaction
- Vessel trauma requiring surgical repair or intervention