SPYGLASS RETRIEVAL BASKET
Received Jul 6, 2023 · Event occurred Jun 9, 2023
Report 3005099803-2023-03468 · MDR key 17273744
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Boston Scientific CorporationModel number
M00546550Catalog number
UNK
Lot number
0028792389
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET DETACHED INTO THE PATIENT'S COMMON BILE DUCT. THE DETACHED BASKET WAS RETRIEVED USING A RESCUE FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYBASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK E1: (B)(6). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHED. IMDRF IMPACT CODE F2301 IS BEING USED FOR THE REPORTABLE EVENT OF RESCUE FORCEPS USED TO RETRIEVE THE BASKET.