BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET

    MDR report key: 2890532 · Received November 30, 2012

    Report

    Report Number
    2890532
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    DURING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE TRAPEZOID MECHANICAL LITHOTRIPSY BASKET WAS USED IN ATTEMPT TO GRASP A VERY LARGE COMMON BILE DUCT (CBD) STONE AND CRUSH THE STONE. BASKET UNABLE TO CRUSH STONE AND BROKE LEAVING BASKET IN CBD. ATTEMPT TO RETRIEVE BASKET UNSUCCESSFUL. ERCP TO BE REPEATED IN A FEW WEEKS GIVEN TRAPPED BILIARY EXTRACTION BASKET AND LARGE RETAINED CBD STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC * 15340612

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR