BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1150254 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04280
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STONE RETRIEVAL PROCEDURE WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. AN RX LITHOTRIPTER BASKET HAD BEEN ADVANCED TO CAPTURE A STONE WITHIN THE BILIARY DUCT. AFTER CAPTURING THE CALCULI, THE "CRUSHING WAS NOT EFFECTIVE". THE BASKET TIP DID NOT DISENGAGE. THE PHYSICIAN WAS UNABLE TO RELEASE THE CALCULI AND THE UNSPECIFIED TYPE OF ENDOSCOPE COULD NOT BE REMOVED FROM THE PT. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE RX LITHOTRIPTER BASKET FOR "2 HOURS". AT AN UNSPECIFIED TIME, THE PHYSICIAN "CUT THE WIRES WITH A WIRE CUTTING PLIERS". THE PT EXPERIENCED "TRAUMA OF THE PRIMARY BILIARY DUCT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890 11696962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R