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

Model Number	M0063902010
Medical Device Problem Codes	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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an escape basket device was about to be used during a rigid ureteroscopic lithotripsy procedure.During unpacking, it was found that the tip of the sheath at the distal part 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 facility name: (b)(6).Block h6: device code a0414 captures the reportable event of sheath torn at distal section.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device code a0414 captures the reportable event of sheath torn at distal section.Investigation results: the returned escape basket was analyzed, and it was noted that the handle returned in good condition.A visual evaluation also noted that the basket partially opened.Media analysis was performed, and it showed that the sheath was torn close to the black heat shrink.Microscopic examination was performed under magnification, and it was possible to see that the sheath was torn close to the black heat shrink.Additionally, the sheath was bent in the center.With all the available information, boston scientific concludes that the reported event of sheath torn material was confirmed; however, the investigation findings did not lead to a clear conclusion about the cause of this failure.As per additional information requested to the manufacturing team, during manufacturing process, device inspections are conducted to ensure the integrity of the device and that the product builders would have notice the encountered failure.During the analysis, it was also observed that the sheath was bent in the center, this finding 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 the bent observed in the sheath.Taking all available information into consideration an investigation conclusion code of cause not established was assigned to this investigation since the findings did not lead to a clear conclusion about the cause of the reported event.
Event or Problem Description
It was reported that an escape basket device was about to be used during a rigid ureteroscopic lithotripsy procedure.During unpacking, it was found that the tip of the sheath at the distal part 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: 23127274
• Report Number: 2124215-2025-66941
• Device Sequence Number: 12698176
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)270708(10)34384126
• 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): 11/06/2025

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: 0034384126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 80 KG