CAPTIVATOR? COLD

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP FAILURE TO CUT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COLD SNARE WAS USED FOR A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE SNARE FAILED TO CUT THE POLYP. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.