Description of Event or Problem · 1
ON MARCH 19, 1992 PATIENT WAS TO UNDERGO A SPLENIC ARTERY EMBOLIZATION. UNDER THE SUPERVISION OF AN ATTENDING RADIOLOGIST, THE RESIDENT RADIOLOGIST BEGAN THE PROCEDURE, UTILIZING A 6.5 FRENCH ROSCH CELIAC CATHETER AND A 0.35" RADIFOCUS GUIDEWIRE M. THE CATHETER WAS PLACED WITHOUT DIFFICULTY IN THE PROXIMAL SPLENIC ARTERY AND A SPLENIC ARTERIOGRAM WAS ACCOMPLISHED. EFFORTS WERE THEN UNDERTAKEN TO ADVANCE THE CATHETER TO THE SPLENIC HILUM. THE PROCEDURE WAS BEING CLOSELY OBSERVED ON THE FLUOROSCOPIC MONITOR AND THE MANIPULATION OF THE CATHETER AND GUIDEWIRE WAS REMARKABLE. THE PATIENT COMPLAINED OF SUDDEN, SEVERE SHARP SUBSTERNAL CHEST PAIN. VITAL SIGNS AND HEART RYTHMS, HAVING BEEN MONITORED THROUGHOUT THE PROCEDURE, REMAINED UNCHANGED INITIALLY. WITHIN A BRIEF PERIOD OF TIME, HOWEVER, THE PATIENT COMPLAINED OF SEVERE SHORTNESS OF BREATH, BECAME UNCONSCIOUS AND HYPOTENSIVE. THE PROCEDURE WAS TERMINATED AND THE CATHETER AND GUIDEWIRE WERE REMOVED. A CODE WAS INITIATED, THE RESULTS OF WHICH WERE UNSUCESSFUL. IT WAS INITIALLY THROUGH THAT THE PATIENT HAD SUFFERED A SEIZURE OR CARDIAC EVENT. AN AUTOPSY REPORT, RECEIVED FROM THE MEDICAL EXAMINER'S OFFICE ON 5/11/92, INDICATED THE CAUSE OF DEATH TO BE PERITONEAL HEMORRAGE DUE TO THE PERFORATION OF THE SPLENIC ARTERY DURING ARTERIAL EMBOLIZATONDEVICE 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.DEVICE WAS EVALUATED AFTER THE 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: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.