MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL BASKET; DISLODGER, STONE, BILIARY

Model Number	M00546550
Medical Device Problem Codes	Difficult to Advance (2920); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf impact code f1001 captures the reportable event of procedure aborted/cancelled.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a spybasket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2024.During the procedure, the basket was unable to open within the spyglass catheter and the physician felt resistance while advancing the basket.As a result, the procedure has been cancelled.There were no patient complications as a result of this event.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough 01752 ; 5086834015
• MDR Report Key: 19777403
• Report Number: 3005099803-2024-03395
• Device Sequence Number: 12869002
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K071066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: M00546550
• Device Lot Number: 0031501746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/18/2024
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown