MalfunctionFGX
CAPTIVATOR? COLD
Received Jun 15, 2026 · Event occurred May 1, 2026
Report 3005099803-2026-02440 · MDR key 25498616
Device
Generic name
Snare, Non-electrical
Manufacturer
Boston Scientific CorporationModel number
M00561100Catalog number
M00561100
Lot number
0038426624
Product problems
- Failure to Cut
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
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.