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

Model Number	M00535130
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, when the device was bowed, the orientation of the cutting wire was different from usual.The procedure was completed with another of the same device.There were no reported patient complications as a result after this event.This event has been deemed a reportable event based on the investigation finding of cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: investigation results the returned stonetome was analyzed, and a visual inspection found that the working length was twisted and kinked, also, the cutting wire was kinked, due these damages the wire was misaligned with the working length.No other problems with the device were noted.The results of the analysis performed on the returned device found that the cutting wire was kinked.This problem could be caused by operational factors, such as manipulating the device through difficult anatomy, the used technique for the device manipulation or by the interaction between the device and the scope (hitting against a hard surface) or it got stuck somewhere.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22813110
• Report Number: 3005099803-2025-03939
• Device Sequence Number: 8756615
• Product Code: LQR
• UDI-Device Identifier: 08714729146575
• UDI-Public: (01)08714729146575(17)270309(10)36024628
• 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
• Report Date (Section B): 08/15/2025

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: M00535130
• Device Catalogue Number: M00535130
• Device Lot Number: 0036024628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2025
• 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