BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 24938268 · Received April 21, 2026

    Report

    Report Number
    3005099803-2026-01454
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296409
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT TIP FAILURE TO SEPARATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED IN THE COMMON BILE DUCT FOR BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE MECHANICAL LITHOTRIPSY AND STONE RETRIEVAL DEVICE WAS DIRECTLY DAMAGED AND STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492722 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510890 0036975515 08714729296409

    Patients

    Seq Age Sex Outcome Treatment
    1