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

Model Number	M00535150
Medical Device Problem Codes	Failure to Conduct (1114); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the papilla during a stone removal surgery procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, energization was not possible, and incision could not be performed.The procedure was completed with a different 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 a cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter's city and province is (b)(6) prefecture; reported here as the initial reporter's city and province exceeded the character limit for the designated field.Block h6: imdrf device code a0406 captures the reportable investigation result of wire kinked.Block h11: investigation results the returned stonetome was analyzed, and a visual inspection found that the cutting wire was kinked.An electrical test was performed, the resistance across the 2-in-1 connector and the cutting wire must be less than or equal to 20ohms, the result was 14.6 ohms, within specification, the device also showed continuity.No other problems with the device were noted.The results of the analysis performed on the returned device found that the cutting wire was kinked.This problem could be caused by operational factors, such as the used technique for the device manipulation or by the interaction between the device and a hard surface.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.

• 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: 23441331
• Report Number: 3005099803-2025-05727
• Device Sequence Number: 4632845
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: (01)08714729146667(17)270404(10)36229840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191789
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: M00535150
• Device Catalogue Number: M00535150
• Device Lot Number: 0036229840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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