COOK HIGH-FLO TORQUE CONTROL COBRA VISCERAL CATHETER

Description of Event or Problem

AORTOBIFEMORAL BYPASS GRAFT PERFORMED PRIOR TO 11/4/92; ARTEROGRAM PERFORMED 11/4/92. NO DAMAGE TO CATHETER, AND NO COMPLICATIONS WERE NOTED. ULTRASONIC EVALUATION PERFORMED 12/16/92, ON A MASS IN THE RIGHT GROIN. RESULTS INDETERMINATE. SURGERY PERFORMED ON 12-17-92. FOREIGN BODY REMOVED, AND IDENTIFIED AS PIECES OF A CATHETERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.