Description of Event or Problem · 1
THE DISTRIBUTOR BECAME AWARE ON JULY 26, 1993 OF AN ACCIDENT WHICH OCCURRED DURING A SURGICAL WORK-UP BILATERAL AORTO ILIAC FEMORAL ARTERIOGRAM WHILE USING A GLIDEWIRE THROUGH AN ENTRY NEEDLE. AFTER MUCH MANIPULATION, AND A FAILED ATTEMPT TO ACQUIRE ACCESS, THE GLIDEWIRE WAS REMOVED. IT WAS NOTED AT THAT TIME THE COATING HAD SHEARED AND DETACHED IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY. SURGICAL RETREIVAL OF THE COATING WAS SUCCESSFUL AND THE PATIENT EXPERIENCED NO SEQUELAE TO THIS EVENT. THE PRE-SCHEDULED SURGERY FOR BY-PASS GRAFT WAS NOT AFFECTED BY THIS INCIDENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.