BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1111622 · Received August 13, 2008

    Report

    Report Number
    3005099803-2008-02183
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP), A WIRE BREAKAGE OCCURRED. THE PROCEDURE WAS BEING PERFORMED FOR REMOVAL OF GALLSTONES FROM THE COMMON BILE DUCT (CBD). AN JAGWIRE GUIDE WIRE WAS PLACED AND A SPHINCTEROTOMY WAS PERFORMED WITH AN UNSPECIFIED DEVICE. THE RX LITHOTRIPTER COMPATABLE BASKET WAS ADVANCED TO THE CBD. UPON ATTEMPTING TO RETRIEVE A STONE, "ONE OF THE FOUR BASKET WIRES RELEASED BY ITSELF". THE BASKET WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS NOT AVAILABLE, THEREFORE, THE PHYSICIAN DECIDED AGAINST FURTHER ATTEMPTS TO RETRIEVE THE STONE AND PLACED AN UNSPECIFIED BILIARY STENT. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890 11671616

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR