Description of Event or Problem · 1
PATIENT HAD CARDIAC CATH IN LAB AT WHICH TIME INTRODUCER WAS INSERTED. AFTER THE PATIENT HAD LEFT THE CATH LAB, IT WAS FOUND THAT THE DIAPHRAM END OF INTRODUCER HAD BECOME DISCONNECTED. IT APPEARED THE BOND HAD COME LOOSE. PATIENT BEGAN TO HEMORRHAGE. PATIENT WAS RETURNED TO CATH LAB DUE TO INCREASED CHEST PAIN AFTER BLEEDING CONTROLLED. PATIENT WENT ON TO HAVE AN M.I.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, NONE OR UNKNOWN, HUB. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.