BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 2250819 · Received August 30, 2011

    Report

    Report Number
    2250819
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A STONE CAUSING AN OBSTRUCTION WAS SEEN AT THE MAIN PANCREATIC DUCT. A BALLOON WAS INTRODUCED FOR DILATION AND THE DIAMETER PROGRESSIVELY INCREASED. AN ATTEMPT TO EXTRACT THE STONE WAS PARTIALLY SUCCESSFUL USING A TRAPEZOID SNARE. ELECTROHYDRAULIC LITHOTRIPSY WAS PERFORMED AND THE STONE WAS FRAGMENTED. SEVERAL FRAGMENTS WERE REMOVED USING A BALLOON AND A BASKET. DURING EXTRACTIONS, A LARGE FRAGMENT STILL REMAINED. A MECHANICAL LITHOTRIPTOR WAS INSERTED AND DURING AN ATTEMPT AT FRACTURING THE STONE, THE LITHTRIPTOR WIRE BROKE. MULTIPLE ATTEMPTS TO CLEAR THE LITHOTRIPTOR FROM THE STONE WERE UNSUCCESSFUL. AN OUT OF THE SCOPE LITHOTRIPTOR WAS ATTEMPTED, HOWEVER, THE WIRE AGAIN BROKE DURING THE ATTEMPT AT LITHOTRIPSY. AN ARGON-PLASMA COAGULATOR WAS APPLIED FOR ABLATION OF TWO OF THE LITHOTRIPTOR BASKET WIRES SUCCESSFULLY AND THE LITHOTRIPTOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX MECHANICAL LITHOTRIPSY SYSTEM LQC BOSTON SCIENTIFIC 1087 14437468

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NO OTHER THERAPIES