SPYGLASS RETRIEVAL SNARE

Additional Manufacturer Narrative

(B)(4). BLOCK H10: A VISUAL ASSESSMENT WAS PERFORMED AND FOUND THAT THE PEEK EXTRUSION WAS DETACHED FROM THE HANDLE. THE HANDLE WAS ACTUATED. THE LOOP COULD NOT BE EXTENDED DUE TO THE SECTION OF THE DEVICE THAT WAS FOUND TO BE DAMAGED (PEEK EXTRUSION DETACHED), CONFIRMING THE COMPLAINT. THE LOOP WAS DETACHED FROM THE METAL CANNULA FROM THE DISTAL SECTION OF THE DEVICE. THE METAL CANNULA WAS INSPECTED. GLUE RESIDUES AND CRIMP MARKS WERE OBSERVED, INDICATING THAT THE DEVICE WAS PROPERLY ASSEMBLED DURING THE MANUFACTURING PROCESS. THE FAILURE OF LOOP DETACHED IS AN ISSUE THAT COULD HAVE BEEN GENERATED BY EXCESSIVE MANIPULATION OF THE DEVICE BY THE USER AND/OR EXCESS OF FORCE APPLIED TO THE DISTAL SECTION OF THE DEVICE. THEREFORE, THE APPROPRIATE CONCLUSION CODE IS CAUSE TRACED TO COMPONENT FAILURE, SINCE THE FAILURE WAS AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. THE REVIEW CONFIRMED THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO SPYSNARES BROKE WHILE TRYING TO RETRIEVE A PLASTIC STENT. ONE OF THE SPYSNARES HAD THE LOOP WIRE BREAK INSIDE THE PATIENT. THE LOOP WIRE WAS RETRIEVED WITH A FORCEP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO SPYSNARES BROKE WHILE TRYING TO RETRIEVE A PLASTIC STENT. ONE OF THE SPYSNARES HAD THE LOOP WIRE BREAK INSIDE THE PATIENT. THE LOOP WIRE WAS RETRIEVED WITH A FORCEP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.