Captivator COLD Single-use snare

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER AND UPN NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF DEVICE FAILURE TO CUT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD SNARE WAS USED IN AN UNKNOWN PROCEDURE DURING AN UNKNOWN DATE. THE PHYSICIAN NOTICED THE SNARE WAS NO LONGER CUTTING AS EFFECTIVELY AS IN PREVIOUS EXPERIENCES. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO COLD CUT THROUGH THE MUCOSA WHEN THERE WAS REPETITION. BLEEDING WAS REPORTED AT THE PATIENT'S DEFECT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.