Description of Event or Problem · 1
ON MAY 4, 1992, A PATIENT UNDERWENT A FEMORAL ATHRECTOMY. DURING THE PROCEDURE THE GUIDEWIRE BROKE OFF WHILE IN THE PATIENT. THE WIRE WAS RETRIEVED THROUGH A POPLITEAL APPROACH USING A SNARE. THE THEORY, BY THE PHYSICIAN AND SERVICE REPRESENTATIVE, WHO WAS COINCIDENTALLY PRESENT, WAS THAT A SEVERE KINK IN THE WIRE HAD OCCURRED WHICH WOULD NOT ALLOW THE SHAFT TO SPIN FREELY OVER IT, CAUSING THE SHAFT TO STRESS AND BREAK.THE PATIENT HAD NO COMPLICATIONS FROM THIS INCIDENT. THE PROCEDURE CONTINUED AFTER THE WIRE TIP WAS REMOVED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.