CAPTIVATOR COLD SINGLE-USE SNARE

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP FAILURE TO CUT. DEVICE EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE CUSTOMER THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE ISSUE WAS INDUCED BY THE PHYSICIAN TECHNIQUE DURING THE PROCEDURE OR IT WAS RELATED TO A DEVICE MALFUNCTION, "CAUSE NOT ESTABLISHED" IS SELECTED AS THE MOST PROBABLE CAUSE FOR THIS EVENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE WAS USED FOR A FLEXI SIGMOIDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE PRESENTED EXTENSION AND RETRACTION ISSUES MAKING IMPOSSIBLE TO CUT THE POLYP. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.