MalfunctionFGX
CAPTIVATOR¿ COLD
Received Jun 29, 2026 · Event occurred May 12, 2026
Report 25650491 · MDR key 25650491
Device
Generic name
Snare, Non-electrical
Manufacturer
Boston Scientific CorporationModel number
M00561100Catalog number
M00561100
Lot number
38713283
Patient
44 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE USED THE DEVICE ONCE, NO ISSUE. THE SECOND TIME, WE NOTICED THE WIRE HAD SPLIT WHEN WE EXTENDED IT OUTWARD, INSIDE OF THE PATIENT. NO INJURY WAS CAUSED AND WE SAFELY REMOVED THE DEVICE. NO BROKEN PIECES WERE LEFT BEHIND.