SPYGLASS RETRIEVAL BASKET
Received Dec 28, 2021 · Event occurred Nov 29, 2021
Report 3005099803-2021-07852 · MDR key 13095335
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Boston Scientific CorporationModel number
M00546550Lot number
0027614735
Product problems
- Difficult to Open or Close
- Appropriate Device Problem Term/Code Not Available
- Difficult to Open or Close
- Appropriate Device Problem Term/Code Not Available
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 SPYGLASS RETRIEVAL BASKET WAS USED IN THE BILE DUCT ON A STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SPYBASKET BASKET FAILED TO OPEN. THE PROCEDURE WAS NOT COMPLETED SINCE IT WAS TAKING LONGER THAN EXPECTED. THE PHYSICIAN DECIDED TO RETRIEVE THE STONE AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.