SPYGLASS RETRIEVAL BASKET
Received Apr 1, 2025 · Event occurred Feb 27, 2025
Report 3005099803-2025-01274 · MDR key 21742277
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Boston Scientific CorporationModel number
UNK-P-SPYBASKETCatalog number
UNK-P-SPYBASKET
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
55 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND SERIAL NUMBER; THEREFORE, THE UNIQUE IDENTIFIER (UDI) #, MANUFACTURE DATE, AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE A051104 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE STONE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGERY.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE BILE DUCT DURING A CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BASKET WAS STUCK IN THE BILE DUCT. THE PATIENT HAD SURGERY FEW DAYS LATER TO REMOVE THE BASKET.