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); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of pull wire detached.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported that a escape basket device was used during a flexible transurethral ureterolithotripsy (f-tul) procedure.During the procedure, a wire got damage on the sheath and disconnected from the handle.Additionally, the outer sheath got separated around the middle part.Reportedly, the part of the outer sheath remained inside the patient and was eventually removed using a forceps.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem) block h6 (device code).Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.Investigation results: the returned escape basket was analyzed, and the handle returned in good condition.Microscopic examination was performed under magnification, and it was noticed that the sheath detached and kinked at the middle section.With all the available information, boston scientific concludes that the reported event of sheath break was confirmed due to the separation of the sheath based on the objective evidence of the product analysis.However, it was not possible to identify any evidence of the sheath being torn on the device since the sheath was not torn.Based on the investigation result, these could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to the observed damages.Additionally, during manufacturing process inspections are performed to ensure the integrity and functionality of the device and would have captured the problems found.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 a escape basket device was used during a flexible transurethral ureterolithotripsy (f-tul) procedure.During the procedure, outer sheath wire got damage and separated from the handle around the middle part.Reportedly, the part of the outer sheath detached and remained inside the patient but eventually removed 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: 22577281
• Report Number: 2124215-2025-49223
• Device Sequence Number: 9646818
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)271209(10)35448908
• 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): 08/27/2025

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: 0035448908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• 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: 08/04/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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: Unknown