MalfunctionFGX
CAPTIVATOR COLD SINGLE-USE SNARE
Received Jul 15, 2026 · Event occurred Jun 17, 2026
Report 3005099803-2026-02822 · MDR key 25829154
Device
Generic name
Snare, Non-electrical
Manufacturer
Boston Scientific CorporationModel number
M00561103Catalog number
M00561103
Lot number
0039221809
Product problems
- Failure to Cut
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 CORPORATION THAT A COLD SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. 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.