NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-01651, 3005099803-2010-01658, 3005099803-2010-01654 AND 3005099803-2010-01670 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE, A SPYSCOPE ACCESS AND DELIVERY CATHETER, AN AUTOTOME RX SPHINCTEROTOME, A DREAMWIRE, AND A EXTRACTOR RX RETRIEVAL BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B) (6) 2010. DURING THE ERCP PROCEDURE, A DREAMWIRE GUIDEWIRE WAS INSERTED INTO THE DUODENAL SCOPE AND POSITIONED WITHIN THE COMMON BILE DUCT. THE PHYSICIAN THEN PASSED AN AUTOTOME DEVICE OVER THE DREAMWIRE. THE AUTOTOME WAS REMOVED FROM THE PATIENT. AN EXTRACTOR BALLOON WAS USED TO REMOVE SEVERAL STONES FROM THE COMMON BILE DUCT. THE EXTRACTOR BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THE SPYGLASS SYSTEM WAS THEN USED TO INSPECT THE COMMON BILE DUCT. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE POSITIONED WITHIN THE DUCT; THE DUCT WAS OBSERVED TO BE NORMAL WITH MINOR DEBRIS. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE REMOVED FROM THE PATIENT. AT THIS TIME, THE PATIENT DESATURATED AND A CODE WAS CALLED BY THE ANESTHESIOLOGIST. THE PATIENT EXPIRED IMMEDIATELY AFTER THE REMOVAL OF THE DEVICE. NO ABNORMALITIES OR DEVICE MALFUNCTIONS WERE REPORTED DURING THE ERCP PROCEDURE. AT THIS TIME, THE FACILITY DOES NOT ATTRIBUTE THE PATIENT DEATH TO ANY BSC PRODUCT USED DURING THE CASE. THE FACILITY WOULD NOT RELEASE THE AUTOPSY REPORT, HOWEVER THEY STATED THAT THE REPORT INDICATED "NO KNOWN CAUSE OF DEATH" AND THEY SAW NOTHING IN THE AUTOPSY TO INDICATE THAT THERE WERE ANY ISSUES IN THE AREA THAT THE ERCP WAS PERFORMED.
D
Patient 1
NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-01651, 3005099803-2010-01658, 3005099803-2010-01654 AND 3005099803-2010-01670 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE, A SPYSCOPE ACCESS AND DELIVERY CATHETER, AN AUTOTOME RX SPHINCTEROTOME, A DREAMWIRE, AND A EXTRACTOR RX RETRIEVAL BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B) (6) 2010. DURING THE ERCP PROCEDURE, A DREAMWIRE GUIDEWIRE WAS INSERTED INTO THE DUODENAL SCOPE AND POSITIONED WITHIN THE COMMON BILE DUCT. THE PHYSICIAN THEN PASSED AN AUTOTOME DEVICE OVER THE DREAMWIRE. THE AUTOTOME WAS REMOVED FROM THE PATIENT. AN EXTRACTOR BALLOON WAS USED TO REMOVE SEVERAL STONES FROM THE COMMON BILE DUCT. THE EXTRACTOR BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THE SPYGLASS SYSTEM WAS THEN USED TO INSPECT THE COMMON BILE DUCT. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE POSITIONED WITHIN THE DUCT; THE DUCT WAS OBSERVED TO BE NORMAL WITH MINOR DEBRIS. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE REMOVED FROM THE PATIENT. AT THIS TIME, THE PATIENT DESATURATED AND A CODE WAS CALLED BY THE ANESTHESIOLOGIST. THE PATIENT EXPIRED IMMEDIATELY AFTER THE REMOVAL OF THE DEVICE. NO ABNORMALITIES OR DEVICE MALFUNCTIONS WERE REPORTED DURING THE ERCP PROCEDURE. AT THIS TIME, THE FACILITY DOES NOT ATTRIBUTE THE PATIENT DEATH TO ANY BSC PRODUCT USED DURING THE CASE. THE FACILITY WOULD NOT RELEASE THE AUTOPSY REPORT; HOWEVER, THEY STATED THAT THE REPORT INDICATED "NO KNOWN CAUSE OF DEATH" AND THEY SAW NOTHING IN THE AUTOPSY TO INDICATE THAT THERE WERE ANY ISSUES IN THE AREA THAT THE ERCP WAS PERFORMED.
N
Patient 1
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B) (4)
N
Patient 1
FOLLOW UP INFORMATION RECEIVED BY THE COMPLAINANT REVEALED THAT THE PATIENT WAS BEING TREATED FOR CHOLEDOCOLITHIASIS. ALL THE STONES WERE REMOVED. THE PATIENT CODED DURING THE PROCEDURE DUE TO THE LACK OF OXYGEN CAUSED BY AN OBSTRUCTION OR ISSUE RELATED TO THE ANESTHESIA. THE COMPLAINANT WOULD NOT OFFER INFORMATION REGARDING THE PATIENT?S MEDICAL HISTORY. (B) (4)