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

Model Number	M00535130
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used during an endoscopic stone removal procedure performed on (b)(6) 2024.During the procedure, the knife was operated using the proximal handle, but the tip of the knife did not move, so it was removed.The procedure was completed with a second 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 results: wire broken.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results: the returned stonetome was analyzed, and a visual and microscopic inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.No other problems with the device were noted.It was found during the investigation of the returned device that the cutting wire was kinked and broken from the proximal pierce hole.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Wire broken could have been generated if there was contact between the device and the scope during energization or if the device exceeds the maximum of voltage during procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, also it can cause a premature cutting wire fatigue, leading to break it.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire.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: 21417337
• Report Number: 3005099803-2025-00579
• Device Sequence Number: 9198701
• Product Code: LQR
• UDI-Device Identifier: 08714729146575
• UDI-Public: 08714729146575
• 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): 02/19/2025

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 Expiration Date: 04/22/2026
• Device Model Number: M00535130
• Device Catalogue Number: M00535130
• Device Lot Number: 0033877331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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