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

Model Number	M00535130
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981); 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	05/01/2025
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 an unknown date.It was reported that the tip of the knife was oriented differently than intended.A photo of the complaint device was provided by the complainant where it can be observed that the working length was kinked and twisted.The procedure was completed with another stonetome.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.H6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.H11: investigation results: the returned stonetome was analyzed, and a visual and microscopic inspection found that the working length was bent and twisted, additionally, the cutting wire was popping out from the working length, it was kinked and not aligned to the working length as well.The device was observed under magnification and was observed that the distal pierce hole was torn.Media inspection was performed based on the pictures provided by the customer where it was possible to observe the device bowed, the working length was twisted.No other problems with the device were noted.The results of the analysis performed on the returned device found that the working length was bent, the cutting wire was kinked and popped out, also, the distal pierce hole was observed torn.The cutting wire kinked found 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), once the cutting wire is kinked, is possible that it may get stuck or "caught" somewhere, causing the cutting wire to pop out and tearing the pierce hole (working length).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: 22720841
• Report Number: 3005099803-2025-03697
• Device Sequence Number: 9501786
• Product Code: LQR
• UDI-Device Identifier: 08714729146575
• UDI-Public: (01)08714729146575(17)261024(10)35142937
• 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): 08/05/2025

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: 3513
• Device Lot Number: 0035142937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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