CAPTIVATOR COLD
Received Jun 18, 2026 · Event occurred May 20, 2026
Report 3005099803-2026-02517 · MDR key 25545972
Device
Generic name
Snare, Non-electrical
Manufacturer
Boston Scientific CorporationModel number
M00561100Catalog number
M00561100
Lot number
0038439443
Product problems
- Detachment of Device or Device Component
Patient
43 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
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 WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE METAL WIRE OF THE SNARE BECAME DETACHED FROM THE PLASTIC COMPONENT OF THE DEVICE, RESULTING IN IMMEDIATE LOSS OF FUNCTIONALITY AND INABILITY TO USE THE DEVICE AS INTENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVE
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF LOOP DETACHMENT OF DEVICE OR DEVICE COMPONENT.