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

Model Number	M0063902010
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detachment.
Event or Problem Description
It was reported that during a flexible ureteroscopic lithotripsy procedure, an escape basket was intended to be used.When the physician opened the package, it was found that the tip of the basket was missing.The procedure was completed using another device of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detachment.Block h11: the returned escape device was analyzed.The basket was not visible upon initial inspection.During the inspection, it was found that the heat shrink was kinked and the sheath was detached.One of the detached sheath segments was gently pulled to expose the basket, and it came out.During media inspection, the image showed one escape device in which the basket was not visible, and a detachment in the sheath was observed.During microscope inspection, the device was evaluated under magnification, and it was confirmed a kinked heat shrink and a detached sheath.During functional inspection, the handle was actuated; however, the basket was not able to open or close due to the detachment identified.Based on the product investigation, the escape device presented a kinked heat shrink and a detached sheath.Additionally, it was identified that due to the detachment, the sheath had shifted and was covering the basket, giving the appearance that the basket was not visible.Once the detached sheath segment was gently manipulated, the basket was exposed.Therefore, the originally reported issue could not be confirmed, as the basket was present and not missing.The detachment and kinking observed may be related to handling and manipulation of the device during preparation or use.It is probable that excessive force or operational factors contributed to the detachment, deformation identified and the failure opening.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of basket detachment of device or device component, sheath detached/separated, basket opening failed and system damaged (heat shrink kinked) were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, an investigation conclusion code of device problem excluded was assigned to this investigation as the reported device problem cannot be confirmed.
Event or Problem Description
It was reported that during a flexible ureteroscopic lithotripsy procedure, an escape basket was intended to be used.When the physician opened the package, it was found that the tip of the basket was missing.The procedure was completed using another device of the same device.No patient complications were reported.

• 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: 24352020
• Report Number: 2124215-2026-08695
• Device Sequence Number: 10200452
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: (01)08714729121299(17)280317(10)36090358
• 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): 03/25/2026

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: 0036090358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 68 KG