BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME

    MDR report key: 24075991 · Received January 14, 2026

    Report

    Report Number
    3005099803-2026-00209
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    November 20, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQR
    UDI-DI
    08714729146667
    PMA / PMN Number
    K191789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 A040601 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 AT DISTAL SECTION, ALSO, THE CUTTING WIRE WAS BENT, DUE THESE CONDITIONS THE WIRE WAS NOT ALIGNED 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, THE USED TECHNIQUE FOR THE DEVICE MANIPULATION OR BY THE INTERACTION BETWEEN THE DEVICE AND A HARD SURFACE. THE INVESTIGATION FINDINGS AND ALL INFORMATION AVAILABLE CONCLUDES THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTING TO USE THE STONETOME, AN ABNORMALITY WAS OBSERVED IN THE DIRECTION OF THE CUTTING WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135924 STONETOME DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC CORPORATION M00535150 0036229840 08714729146667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown