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Patient 1
WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. WE OBSERVED THAT ONE OF THE BLADES WAS PROTRUDING OUT OF THE RETAINER IN ITS CLOSED CONFIGURATION. THE CENTERING HOOP OF THIS SAME BLADE WAS ALSO FOUND BENT. OUR LOT HISTORY RECORDS REVIEW FOR THIS LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR PACKAGING PROCESSES. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY GROUP ALSO SAMPLES THESE DEVICES BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. IT IS POSSIBLE THAT THE BLADE WAS DAMAGED DURING PACKAGING OR DURING SHIPPING THE DEVICE TO THE HOSPITAL. IT IS ALSO POSSIBLE THAT THIS DEVICE WAS HANDLED AGGRESSIVELY AT THE USER FACILITY DURING PRE-USE CHECK THAT COULD HAVE LED TO THIS DEFECT. DURING OUR EVALUATION, WE ALSO OBSERVED A HEAVY KINK AT THE MIDDLE OF THIS DEVICE ALTHOUGH THIS DEVICE WAS REPORTED TO BE NOT USED IN A PATIENT. WHILE WE ARE INCONCLUSIVE ABOUT THE EXACT ROOT CAUSE OF THE DEFECT IN THIS DEVICE, WE HAVE IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS TYPE OF ISSUE. IN THE CAPA, WE HAVE MADE A SERIES OF IMPROVEMENTS AND REPLACEMENTS TO OUR MANUFACTURING FIXTURES TO RESOLVE THIS ISSUE. THE CORRECTIVE ACTIONS THAT WE HAVE IMPLEMENTED HAVE REDUCED THE RATE OF FAILURE WITH THIS DEVICE FOR THIS ISSUE. OUR IFU CLEARLY INFORMS USERS TO INSPECT THE BLADES FOR DAMAGE AND ALIGNMENT PRIOR TO USE. IN THIS CASE, THE USER PROPERLY FOLLOWED THE RISK MITIGATION MEASURES (IFU) AND PROPERLY IDENTIFIED THE ISSUE. DEVICE WAS NOT USED IN THE PATIENT. ANOTHER VALVULOTOME WAS USED FOR THE SURGERY.