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

Model Number	M00535110
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g4: the remaining premarket/510(k) number is k946358; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable investigation result 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 broken and not crimped to the connector joint strength at the handle section.As a result, during attempts to bow, the cutting wire detached from the working length.No other problems with the device were noted.During analysis of the returned device, it was determined that the cutting wire did not have evidence of crimping and was not crimped to the connector joint strength at the handle section during the manufacturing process.The investigation findings and all information available concludes the most probable root cause is manufacturing deficiency.A non-conforming events prevention (ncep) investigation was completed by boston scientific corporation (bsc) to address this problem.The ncep investigation concluded that the referenced event was an isolated event due to human error during manufacturing.A review of the manufacturing process found it likely that a step in the procedure was omitted.The step in which the operator assembles the cutting wire and confirms it is properly positioned was not performed correctly.All applicable product builders were made aware of the event and the procedure was reviewed by all applicable product builders to heighten awareness of the requirements outlined in this manufacturing process.As part of the ncep investigation, a risk assessment was performed.Wire detached/separated is a known and anticipated, potential failure mode outlined in the device risk documentation, and the severity is considered moderate, with an anticipated clinical effect of prolonged procedure.The risk assessment confirmed that the observed severity (harm) and occurrence rankings are within with the anticipated risk level documented in risk documentation, and the risk is acceptable.The investigation is complete and the ncep was closed in october 2024.Bsc will continue to monitor and trend these complaints and associated risks as outlined in our quality systems process.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the papilla during an endoscopic sphincterotomy (est) procedure to treat a bile duct stone performed on (b)(6) 2025.During the procedure, the cutting wire did not move even when the handle was pushed and pulled.The procedure was completed with a different device.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 break.Please see block h11 for full investigation details.

• 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: 22348847
• Report Number: 3005099803-2025-02853
• Device Sequence Number: 18270857
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: (01)08714729146599(17)260827(10)34727841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191789
• 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): 06/27/2025

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: 08/27/2026
• Device Model Number: M00535110
• Device Catalogue Number: M00535110
• Device Lot Number: 0034727841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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