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

Model Number	M0063902010
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a escape basket was about to be used during a rigid ureteroscopic lithotripsy and ureterolithotomy procedure.During preparation, upon opening the package it was found that the tip and tail end of the basket was fractured.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of basket wire detached.
Additional Manufacturer Narrative
Initial reporter address: no.1, (b)(6).Device code a0401 captures the reportable event of basket wire detached.
Event or Problem Description
It was reported that a escape basket was about to be used during a rigid ureteroscopic lithotripsy and ureterolithotomy procedure.During preparation, upon opening the package it was found that the tip and tail end of the basket was fractured.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: device code a0401 captures the reportable event of basket wire detached.Block h11: investigation results: the returned escape basket was analyzed, and it was noted that the handle returned in good conditions.A visual evaluation also noted that the basket returned on its open position and no broken wires were noticed.A media analysis was performed and shows that the device with one of the basket wires broken and fully detached.Microscopic examination was performed under magnification, and it was noticed that the sheath was detached near the black heat shrink.Additionally, the sheath was kinked at the center.With all the available information, boston scientific concludes that the reported event of basket wire break was not confirmed as it was not possible to identify any evidence of the alleged issue on the device since no broken wires were found on the basket.The sheath detached reported by the customer did not lead to a clear conclusion about the cause of the failure.However, the observed findings of basket kinked, and sheath kinked at the center could be related to handling and manipulation of the device during preparation.It is probable that an excess of force applied to the device such as operational factors could have caused these damages observed.Taking all available information into consideration, an investigation conclusion code of cause not established was assigned to this investigation since the findings do not lead to a clear conclusion about the cause of the main adverse event.
Event or Problem Description
It was reported that a escape basket was about to be used during a rigid ureteroscopic lithotripsy and ureterolithotomy procedure.During preparation, upon opening the package it was found that the tip and tail end of the basket was fractured.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: 22588339
• Report Number: 2124215-2025-49479
• Device Sequence Number: 13096652
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)270501(10)33941105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/04/2025

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: 0033941105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 10/10/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/25/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 63 KG