MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number	M00535130
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: (investigation result) the returned stonetome was analyzed, and a visual and microscopic evaluation noted that the cutting wire was bent and the balloon burst.No other problems with the device were noted.The product analysis revealed that the cutting wire was bent.This condition could have been caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Additionally, the balloon burst could have been generated due to the factors encountered during the procedure, the patient anatomy, and the interaction with the scope when the physician advanced the balloon.It can also be caused when the first interaction of the balloon with the stone could have damaged the integrity of the component, inhibiting the capability of the balloon to be inflated again and could have caused that the balloon burst.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, the balloon ruptured immediately upon initial use of the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of cutting wire kinked.Please see block h11 for full investigation details.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23888890
• Report Number: 3005099803-2025-06882
• Device Sequence Number: 4671503
• Product Code: LQR
• UDI-Device Identifier: 08714729146575
• UDI-Public: (01)08714729146575(17)270605(10)36691938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946358
• 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
• Report Date (Section B): 12/24/2025

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: M00535130
• Device Catalogue Number: M00535130
• Device Lot Number: 0036691938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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 Sex: Unknown