Description of Event or Problem · 1
PATIENT DEVELOPED AN OCCLUSION OF THE RIGHT LOWER EXTREMITY ARTERY. ON JUNE 18, 1992 THE PATIENT WAS TAKEN TO SURGERY FOR A RIGHT FEMERAL ARTERY EMBOLECTOMY. DURING SURGERY A FOREIGN BODY WAS REMOVED FROM THE ARTERY. TH PATIENT THEN REQUIRED A FEMORAL-POPLITEAL BYPASS. THE PATHOLOGY REPORT DESCRIBED THE FOREIGN BODY AS BLACK, THREAD-LIKE, SYNTHETIC STRING THAT WAS 21 CM IN LENGTH X .1 CM IN DIAMETER. THE PATIENT HAD NOT HAD ANY PROCEDURES DONE AT OUR FACILITY THAT INVOLVED THE INSERTION OF A CATHETER OR DEVICE INTO THE FEMORAL ARTERY. AT A PRIOR TREATING FACILITY, THE PATIENT HAD A CARDIAC CATHERIZATION DONE. IT IS NOTED ON THE CATH PROCEDURE RECORD THAT THE SIDE OF THE CATH WAS LEFT FEMORAL; RIGHT FEMORAL IS ALSO CHECKED AND "UNABLE TO THREAD WIRE" NOTED NEXT TO THIS SITEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.