SPYGLASS DIRECT VISUALIZATION SYSTEM

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, AFTER CANNULATION, AN EST (ENDOSCOPIC SPHINCTEROTOMY) WAS PERFORMED, AND THE SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED FOR VISUALIZATION AND BIOPSY IN THE BILE DUCT. THERE WERE NO DEVICE ISSUES DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN "UNEXPLAINED RETROPERITONEAL ABSCESS". SINCE THE PATIENT DID NOT HAVE ELEVATED AMYLASE LEVELS THE PHYSICIAN ATTRIBUTED THE RETROPERITONEAL ABSCESS TO EITHER A PERFORATION IN THE PAPILLA DURING THE EST OR TO A PERFORATION IN THE BILE DUCT DURING USE OF THE SPYSCOPE ACCESS AND DELIVERY CATHETER. A FLEXIMA STENT WAS IMPLANTED AND ANTIBIOTICS WERE ADMINISTERED FOR TREATMENT, HOWEVER THE PATIENT'S SYMPTOMS DID NOT IMPROVE. ON (B)(6)2015, ABDOMINAL SURGERY WAS PERFORMED FOR TREATMENT OF THE ABSCESS, AND REVEALED THAT THERE WAS NO PERFORATION. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD A RETROPERITONEAL ABSCESS AND A PERIPANCREATIC NECROTIC CYST CAUSED BY INFECTION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A "BURST PSEUDOANEURYSM", REQUIRING ANOTHER ABDOMINAL SURGERY FOR TREATMENT. THE PATIENT DID NOT RECOVER FROM THIS EVENT AND DIED ON (B)(6) 2015. NO AUTOPSY WAS PERFORMED. IN THE PHYSICIAN'S ASSESSMENT THE CAUSE OF DEATH WAS BLEEDING AND SEPTIC SHOCK. THE PHYSICIAN SUSPECTS THE SPYSCOPE MIGHT HAVE CONTRIBUTED TO THE INFECTION "BY THE APPLICATION OF A STIMULUS TO DUCT OF PANCREAS". HOWEVER THE RELATIONSHIP BETWEEN THE PATIENT DEATH AND THE SPYSCOPE IS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, AFTER CANNULATION, AN EST (ENDOSCOPIC SPHINCTEROTOMY) WAS PERFORMED, AND THE SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED FOR VISUALIZATION AND BIOPSY IN THE BILE DUCT. THERE WERE NO DEVICE ISSUES DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN "UNEXPLAINED RETROPERITONEAL ABSCESS." SINCE THE PATIENT DID NOT HAVE ELEVATED AMYLASE LEVELS THE PHYSICIAN ATTRIBUTED THE RETROPERITONEAL ABSCESS TO EITHER A PERFORATION IN THE PAPILLA DURING THE EST OR TO A PERFORATION IN THE BILE DUCT DURING USE OF THE SPYSCOPE ACCESS AND DELIVERY CATHETER. A FLEXIMA STENT WAS IMPLANTED AND ANTIBIOTICS WERE ADMINISTERED FOR TREATMENT, HOWEVER THE PATIENT'S SYMPTOMS DID NOT IMPROVE. ON (B)(6) 2015, ABDOMINAL SURGERY WAS PERFORMED FOR TREATMENT OF THE ABSCESS, AND REVEALED THAT THERE WAS NO PERFORATION. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD A RETROPERITONEAL ABSCESS AND A PERIPANCREATIC NECROTIC CYST CAUSED BY INFECTION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A "BURST PSEUDOANEURYSM", REQUIRING ANOTHER ABDOMINAL SURGERY FOR TREATMENT. THE PATIENT DID NOT RECOVER FROM THIS EVENT AND DIED ON (B)(6) 2015. NO AUTOPSY WAS PERFORMED. IN THE PHYSICIAN'S ASSESSMENT THE CAUSE OF DEATH WAS BLEEDING AND SEPTIC SHOCK. THE PHYSICIAN SUSPECTS THE SPYSCOPE MIGHT HAVE CONTRIBUTED TO THE INFECTION "BY THE APPLICATION OF A STIMULUS TO DUCT OF PANCREAS." HOWEVER THE RELATIONSHIP BETWEEN THE PATIENT DEATH AND THE SPYSCOPE IS UNKNOWN. ADDITIONAL INFORMATION AS OF NOVEMBER 17, 2015. ACCORDING TO THE COMPLAINANT, THE PSEUDOANEURYSM WAS CONFIRMED ON (B)(6) 2015 WHEN THE ABDOMINAL SURGERY WAS PERFORMED; HOWEVER, IT IS UNKNOWN AS TO WHEN WAS PSEUDOANEURYSM EXACTLY FORMED AND THE REGION OF PSEUDOANEURYSM IS UNKNOWN. THE PHYSICIAN COMMENTED THAT ALTHOUGH THERE IS NO RELATIONSHIP BETWEEN THE DEVICES AND PSEUDOANEURYSM, THE PROCEDURE PERFORMED ON (B)(6) 2015 TOOK A LONGER A TIME THAN EXPECTED AND STRAINED THE PANCREAS, WHICH MAY HAVE CAUSED THE RETROPERITONEAL ABSCESS AND A PERIPANCREATIC NECROTIC CYST.