SPYGLASS RETRIEVAL SNARE

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 IN THE MIDDLE AND UPPER BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSNARE WAS INTRODUCED TO REMOVE A NON-BSC MIGRATED PLASTIC STENT. REPORTEDLY, THE DISTAL END OF THE SPYSNARE DETACHED WHEN IT WAS PULLED OUT WITH THE MIGRATED PLASTIC STENT. REPORTEDLY, THE ENTIRE SPYSNARE (INCLUDING THE SNARE END) WAS REMOVED FROM THE PATIENT. THE PLASTIC STENT WAS SUCCESSFULLY RETRIEVED USING A NON-BSC POLYPECTOMY HANDLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

(DEVICE CODES): PROBLEM CODE 2907 CAPTURES THE REPORTABLE EVENT OF LOOP DETACHED. THE RETURNED SPYSNARE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DISTAL SECTION OF THE SHEATH WAS KINKED IN SEVERAL LOCATIONS. THE SNARE LOOP WAS DETACHED FROM THE HYPOTUBE NOTCHED. THE HYPOTUBE NOTCHED HAD EVIDENCE OF THE CRIMPING PROCESS. THE REPORTED EVENT WAS CONFIRMED. THE ISSUE OCCURRED DURING THE PROCEDURE AND THE DEVICE WAS ABLE TO CATCH THE STENT. THE ISSUE OCCURRED WHEN THE USER WAS PULLING THE DEVICE OUT WITH THE STENT. THIS INDICATES THAT LIKELY THE DEVICE WAS IN GOOD CONDITION. HOWEVER, PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO KINK THE SHEATH. ADDITIONALLY, USER TECHNIQUE AND FORCE APPLIED TO THE DEVICE PULLING THE STENT COULD HAVE CONTRIBUTED WITH THE EVENT. THEREFORE, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED IN THE MIDDLE AND UPPER BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSNARE WAS INTRODUCED TO REMOVE A NON-BSC MIGRATED PLASTIC STENT. REPORTEDLY, THE DISTAL END OF THE SPYSNARE DETACHED WHEN IT WAS PULLED OUT WITH THE MIGRATED PLASTIC STENT. REPORTEDLY, THE ENTIRE SPYSNARE (INCLUDING THE SNARE END) WAS REMOVED FROM THE PATIENT. THE PLASTIC STENT WAS SUCCESSFULLY RETRIEVED USING A NON-BSC POLYPECTOMY HANDLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.