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

Model Number	M00535150
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation result of cutting wire kinked.Block h11: (investigation result) - the returned stonetome was analyzed, and a visual evaluation noted that the cutting wire was kinked.Additionally, the pierce holes were misaligned causing the cutting wire not being aligned with the working length.No other problems with the device were noted.After analysis of the returned device, it was determined that the cutting wire was kinked.These conditions could have been generated due to the device manipulation during its insertion-removal, hitting it against a hard surface (scope).Additionally, the pierce holes were misaligned causing the cutting wire not being aligned with the working length compromising proper device functionality.The specific cause of these conditions could not be determined.An investigation to address this problem is in progress.Based on all gathered information, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2026.During the procedure, when the stonetome was inserted into the endoscope forceps channel and used, the cutting wire appeared to be oriented in the opposite direction than usual.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 results: the cutting wire kinked.Please refer to 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: 25435616
• Report Number: 3005099803-2026-02356
• Device Sequence Number: 10284123
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: (01)08714729146667(17)271118(10)37993188
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: M00535150
• Device Catalogue Number: M00535150
• Device Lot Number: 0037993188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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 Sex: Unknown