BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 977002 · Received January 10, 2008

    Report

    Report Number
    3005099803-2008-00021
    Event Type
    Injury
    Date Received
    January 10, 2008
    Date of Event
    December 6, 2007
    Report Date
    December 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED BUT AN EVALUATION IS NOT COMPLETED; THEREFORE, THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    A TRAPEZOID RX LITHOTRIPTER COMPATIBLE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON A MALE PT IN 2007. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO CRUSH A STONE, "THE BASKET BROKE AND LEFT THE TIP OF THE BASKET AND THE STONE IN THE BILIARY DUCT." A STENT (DEVICE AND MANUFACTURER UNK) WAS PLACED TO AID IN THE DRAINAGE OF THE BILE FROM ETH DUCT UNTIL SURGERY WAS PERFORMED ON TWO DAYS LATER, TO REMOVE THE STONE AND THE BASKET TIP. THE PT'S CONDITION HAS BEEN REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510870 9830187

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention