CAPTIVATOR COLD SINGLE-USE SNARE

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF DETACHMENT OF DEVICE OR DEVICE COMPONENT. BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF ENTRAPMENT OF DEVICE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COLD CUT THE POLYP, BUT AFTER CLOSING IT, THE LOOP DETACHED COMPLETELY FROM THE DEVICE AND FELL OUT INTO THE COLON. THE PIECE BECAME EMBEDDED IN PATIENTS TISSUE AND HAD TO BE RETRIEVED USING A RESCUE NET SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.