MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Stonetome; Dislodger, Stone, Biliary

Model Number	M00535110
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	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: the returned stonetome was analyzed, and a visual evaluation noted that the working length was twisted and the pierce holes were misaligned.Additionally, the cutting wire was not aligned with the curvature of the working length and also was bent.No other problems with the device were noted.The product analysis revealed that the cutting wire was not aligned with the curvature of the working length and also it was bent.This condition could have been generated during manipulation or attempts to orient the cutting wire for insertion and stress was applied to the device, which may have contributed to the cutting wire becoming bent and the working length appearing twisted.Additionally, the cutting wire was not aligned with the curvature of the working length and also was bent.The investigation to address this problem is in progress.Based on all gathered information, the most probable root cause of this complaint is cause linked to device but unable to trace more specifically.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 to treat common bile duct stones performed on (b)(6) 2026.During the procedure, when the blade emerged from the end of the scope, it was facing 1, 2 o clock, making papillotomy difficult.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 ; +1(914)571-6918
• MDR Report Key: 25622842
• Report Number: 3005099803-2026-02581
• Device Sequence Number: 21085451
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: (01)08714729146599(17)270623(10)36816693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: M00535110
• Device Catalogue Number: M00535110
• Device Lot Number: 0036816693
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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