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

Model Number	M0063902010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an escape device was to be used in a rigid ureteroscopic lithotripsy procedure.During unpacking, it was found that the tip of the basket was fractured.The basket wires were broken and one wire was completely detached from the device.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: device code a0401 captures the reportable event of basket wire detachment.
Event or Problem Description
It was reported that an escape device was to be used in a rigid ureteroscopic lithotripsy procedure.During unpacking, it was found that the tip of the basket was fractured.The basket wires were broken and one wire was completely detached from the device.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name:(b)(6).Block h6: device code a0401 captures the reportable event of basket wire detachment.Upon receipt at our quality assurance laboratory, this escape device underwent a thorough analysis.Visual inspection of the device revealed that one basket wire was broken, with evidence of the use of an electrified instrument or laser.The detached portion was not returned.In addition, there was evidence that the basket wire was melted.The handle returned in good conditions and the device returned with the basket on its opened position.The handle was actuated, and the basket was able to close and open properly.Based on the information available and analysis results, the reported event was confirmed.It is possible to conclude that some operational factors, handling and manipulation, such as interaction with an electrified instrument and/or laser could cause the overheating of the basket wire resulting in the breakage.Therefore, an investigation conclusion code of failure to follow instructions was assigned to this investigation.

• 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: 22144500
• Report Number: 2124215-2025-34321
• Device Sequence Number: 7390270
• 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
• Report Date (Section B): 07/18/2025

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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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: 78 KG