CAPTIVATOR COLD SINGLE-USE SNARE

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF SNARE LOOP CUTTING PROBLEMS. BLOCK H11: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PRODUCT ANALYSIS COULD NOT BE CARRIED OUT. FOR THIS REASON AND DUE TO THE LACK OF EVIDENCE, IT IS UNABLE TO CONFIRM THE REPORTED EVENT. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION, AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT CONTRIBUTED TO THE EVENT. THE AS REPORTED IMPACT CODE OF "ADDITIONAL DEVICE REQUIRED" WILL BE CLASSIFIED AS "ADVERSE EVENT RELATED TO PROCEDURE" SINCE THE ADVERSE EVENT OCCURRED DUE TO THE ISSUES ENCOUNTERED DURING PROCEDURE. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS ATTEMPTED TO BE USED TO REMOVE A POLYP. THE CAPTIVATOR WOULD OPEN PARTIALLY BUT NOT COMPLETELY. UNABLE TO FUNCTION PROPERLY AND CUT OUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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.