FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY

Description of Event or Problem

PRIMARY PROCEDURE: REMOTE ENDARTERECTOMY. A PATIENT CAME IN WITH OCCLUDED SFA. THE REMOTE ENDARTERECTOMY HAD TO BE CONVERTED TO FEM-POP DUE TO THE PERFORATION OF THE SFA DUE TO ENDOHELIX DEVICE FAILURE. THE PATIENT IS FINE.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION ON (B)(6) 2011. DURING THE EVALUATION WE FOUND THAT THE SHAFT (OUTER TUBE) OF THE DEVICE WAS BENT AND HELICAL WIRE WAS DETACHED FROM THE TIP. EVEN THOUGH THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE, MOST LIKELY, THE DEVICE USED IN THE PROCEDURE HAD BEEN BENT. THE BEND CREATED ADDITIONAL TENSION FOR THE WIRE AND THE WIRE FAILED DUE TO EXCESSIVE FORCE. THE DETACHED WIRE DAMAGED THE PATIENTS' VESSEL. THE SHAFT COULD BE BENT EITHER DURING THE PHYSICIANS' MANIPULATIONS DURING THE PROCEDURE OR DURING THE SHIPPING AND HANDLING OF THE DEVICE PRIOR TO THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES. HOWEVER, WE HAVE INITIATED THE SUPPLIER CORRECTIVE ACTION FOR OUR SUB-CONTRACTOR TO INVESTIGATE THIS ISSUE IN MORE DETAILS AND TAKE CORRECTIVE ACTION TO PREVENT THIS PROBLEM IN THE FUTURE. PLEASE NOTE THAT NO PATIENT DEATH OR INCAPACITATING INJURIES HAPPENED.