SPYGLASS RETRIEVAL SNARE
Received Apr 6, 2023 · Event occurred Mar 14, 2023
Report 3005099803-2023-01688 · MDR key 16693645
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Boston Scientific CorporationModel number
M00546560Catalog number
4656
Product problems
- Use of Device Problem
- Detachment of Device or Device Component
- Use of Device Problem
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF SNARE LOOP DETACHED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED DURING A METALLIC STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A SPYSNARE LOOP WIRE BROKE INSIDE THE PATIENT WHILE TRYING TO RETRIEVE A METALLIC STENT. THE LOOP WIRE WAS RETRIEVED WITH FORCEPS AND A PLASTIC STENT WAS IMPLANTED SINCE THE METALLIC STENT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.