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	03/25/2026
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 major duodenal papilla (papilla of vater) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a safe papillotomy could not be performed due to unfavorable blade orientation.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results.The returned stonetome was analyzed, and visual inspection found that the working length and the cutting wire were kinked.No other problems with the device were noted.With all the available information, the product analysis of the returned device revealed that the working length and the cutting wire were kinked.These problems could have been caused by attempts to advance the device through a difficult anatomy, device manipulation, or by the device coming into contact with a hard surface (scope).Based on all gathered information, the most probable root cause of this complaint 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.

• 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: 25536442
• Report Number: 3005099803-2026-02506
• Device Sequence Number: 9744365
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: (01)08714729146599(17)271110(10)37921704
• 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): 06/17/2026

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: 0037921704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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