BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME

    MDR report key: 21962020 · Received May 5, 2025

    Report

    Report Number
    3005099803-2025-01938
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQR
    UDI-DI
    08714729146599
    PMA / PMN Number
    K191789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE DURING THE INCISION OF THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513128 STONETOME DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC CORPORATION M00535110 0035384534 08714729146599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown