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

Model Number	M0063902010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); 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	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an escape basket device was about to be use during a ureteroscopic holmium laser lithotripsy and stone removal procedure.Reportedly, during unpacking it was found that the basket was fractured and detached.Additionally, it was noticed that the sheath was torn at the middle part.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: device code a0501 captures the reportable event of basket detached.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket detached.Block h11: investigation results the returned escape basket was analyzed, and a visual evaluation noted that the handle returned in good condition.Media analysis shows that the basket sheath was detached.Microscopic examination was performed under magnification, and it was noticed that the sheath was detached at the center.Additionally, it was also noticed that the sheath kinked at the distal section; however, it was not possible to observe any torn on the device.No other issues were noted with the device.With all the available information, boston scientific concludes that the reported event was not confirmed since it was not possible to identify any evidence of the alleged issues on the device since it was not possible to observe any torn on the device and the basket was properly assembled on the device and it did not have any issue.The observed findings of sheath detached at the center and kinked at the distal section.These 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 lead to detach and kink the sheath.During manufacturing process, an inspection ensures the integrity of the sheath and would have captured the encountered failures.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 about to be use during a ureteroscopic holmium laser lithotripsy and stone removal procedure.Reportedly, during unpacking it was found that the basket was fractured and detached.Additionally, it was noticed that the sheath was torn at the middle part.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: 22048446
• Report Number: 2124215-2025-31819
• Device Sequence Number: 9095889
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)270508(10)33988103
• 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
• Report Date (Section B): 07/24/2025

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: 0033988103
• 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: 04/27/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 70 KG