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	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the papilla during a common bile duct (cbd) stone removal surgery procedure to treat cbd stones performed on (b)(6) 2026.It was reported that the blade was bent.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results at this time the device is currently undergoing technical analysis.The investigation is not yet complete.A supplemental report will be submitted once the results are available.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot numbers, and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the papilla during a common bile duct (cbd) stone removal surgery procedure to treat cbd stones performed on (b)(6) 2026.It was reported that the blade was bent.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 25520909
• Report Number: 3005099803-2026-02474
• Device Sequence Number: 21335626
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: (01)08714729146599
• 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,Followup
• Report Date (Section B): 08/10/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 06/17/2026; 07/15/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/11/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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