MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063902010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an escape basket device was used during a flexible ureteroscopy procedure.During the procedure, the physician was holding the stone with the escape basket; however, one of the basket wires suddenly broke and detached from the basket.Reportedly, they tried to release the stone, but the basket was not working, and basket had to be disabled.The detached wire was retrieved with another basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: impact code f23 captures the reportable event of unexpected medical intervention.Device code a0401 captures the reportable event of basket wire detached.

• Brand Name: ESCAPE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22398594
• Report Number: 2124215-2025-42004
• Device Sequence Number: 4799306
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)271125(10)35361621
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063902010
• Device Catalogue Number: M0063902010
• Device Lot Number: 0035361621
• 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: 06/07/2025
• Initial Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 11/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male