CROSSER CTO RECANALIZATION CATHETER

Additional Manufacturer Narrative

MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. INVESTIGATION SUMMARY: ONE CROSSER 14S CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER WAS SUCCESSFULLY CONNECTED TO AN IN-HOUSE INJECTOR AND GENERATOR. THE DEVICE WAS ABLE TO PRODUCE VIBRATIONS THROUGHOUT THE ENTIRE LENGTH OF THE CATHETER. MISTING WAS OBSERVED COMING OUT FROM THE DISTAL TIP, INDICATING THAT THE DEVICE WAS OPERATING AS EXPECTED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE ALLEGED ACTIVATION ISSUES. UPON COMPLETION OF FUNCTIONAL TESTING, THE DISTAL TIP WAS FOUND TO BE SEPARATED FROM THE OUTER CATHETER. THE INVESTIGATION IS CONFIRMED FOR MATERIAL SEPARATION. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

Description of Event or Problem

IT WAS REPORTED THAT AFTER CONNECTION TO THE TRANSDUCER, THE RECANALIZATION CATHETER ALLEGEDLY WOULD NOT VIBRATE. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.