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

Model Number	M00535110
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of wire break.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the vater papilla during a papillotomy procedure performed on (b)(6) 2025.During the procedure, the knife became separated in the middle of the papillotomy.The procedure was completed using another device of the same type.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of wire break.Block h11: (investigation result).The returned stonetome was analyzed, and a visual and microscopic evaluation noted that the working length was twisted and was torn at distal pierce hole.No other problems with the device were noted.The reported event of cutting wire break was not confirmed.Upon analysis, it was found that the working length was twisted.Based on the condition of the device, the problem could have been caused after multiple attempts to rotate the device or during the introduction of the device into the scope.Additionally, the torn at the distal pierce hole could have been caused by submitting the catheter to tension forces during the handle actuation and bowing the device without being completely out of the scope can lead to tear.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the vater papilla during a papillotomy procedure performed on (b)(6) 2025.During the procedure, the knife became separated in the middle of the papillotomy.The procedure was completed using another device of the same type.No patient complications were 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 ; 9145716918
• MDR Report Key: 23708876
• Report Number: 3005099803-2025-06425
• Device Sequence Number: 10691782
• 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: K946358
• 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,Followup
• Report Date (Section B): 01/15/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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