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

Model Number	M0063902010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an escape basket device was used during a flexible transurethral ureterolithotripsy (f-tul) procedure.During the procedure.A wire on the sheath part got disconnected from the handle.Reportedly, the remaining part was removed inside the patient using a forceps.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of pull wire detached.Impact code f23 captures the reportable event of unexpected medical intervention.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of pull wire detached.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation results: the returned escape basket was analyzed, and a visual evaluation noted that the handle returned in good conditions and the basket returned in its open position.Microscopic examination was performed under magnification, and it was noticed that the sheath detached close to the black heat shrink.Additionally, the sheath was removed and confirmed that the pull wire was detached, indicating that this was related to sheath detachment rather than a pull wire problem.Functional examination was performed with the handle actuated, and the basket was not able to close due to detachment.With all the available information, boston scientific concludes that the reported event was confirmed, since the sheath detachment directly correlates with the reported pull wire detached.This condition could be related to handling and manipulation of the device during the procedure; it is probable that excess force applied to the device, such as operational factors during use, could lead to this type of detachment.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that an escape basket device was used during a flexible transurethral ureterolithotripsy (f-tul) procedure.During the procedure.A wire on the sheath part got disconnected from the handle.Reportedly, the remaining part was removed inside the patient using a forceps.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: 24086256
• Report Number: 2124215-2026-02980
• Device Sequence Number: 9684028
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)280417(10)36327393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 0036327393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown