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

Model Number	M0063902010
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported that an escape retrieval basket was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, it was noticed that the proximal end of the shaft and the wire near the handle was fraying, making it hard to open and close the basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) and block h6 (device code).Block h6: device code a0414 capture that this event will no longer be reportable.
Event or Problem Description
It was reported that an escape retrieval basket was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, it was noticed that the proximal end of the shaft and the outer sheath near the handle was fraying, making it hard to open and close the basket.The procedure was completed with another of the same device with no patient complications.

• 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: 23184631
• Report Number: 2124215-2025-68843
• Device Sequence Number: 21329974
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)280625(10)36845484
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Model Number: M0063902010
• Device Catalogue Number: M0063902010
• Device Lot Number: 0036845484
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 06/26/2025
• 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