Description of Event or Problem · 1
IT BECAMAE AWARE ON MARCH 18., 1994 OF AN INCIDENT INVOLVING THE USE OF A GLIDEWIRE WHILE PERFORMING A CARDIAC CATHETERIZATION. THE GLIDEWIRE, WHICH WAS NOT USED AS THE PRIMARY WIRE WAS ADVANCED THROUGH THE INTRODUCCCCER SHEATH TO THE AORTIC ARCH. THE PHYSICIAN ENCOUNTERED FLUROSCOPY REVEALED COATING FROM THE GLIDEWIRE WAS ATTACHED TO THE DISSTAL END OF THE CATHETER. THE GLIDEWIRE WAS REMOVED AND IT WAS NOTED THAT APPROOX 2-3 INCHES OF COATING WAS MISSING FROM THE WIRE NEAR THE PROXIMAL END. THE CATHETER WAS THEN REMOVED AND ALL THE DETACHED COATING WHICH REMAINED ATTACHED TO THE DISTAL END OF THE GUIDE CATHETER AND THE PT EXPERIENCED NO SEQUELAE AS A RESULT.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 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.