BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1150104 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04207
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    May 13, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    k040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP), A TIP BREAKAGE OCCURRED. THE PROCEDURE WAS BEING PERFORMED FOR REMOVAL OF GALLSTONES FROM AN UNSPECIFIED LOCATION. TWO LARGE STONES WERE REMOVED. UPON ADVANCING THE RX LITHOTRIPTER COMPATIBLE BASKET IN AN ATTEMPT TO RETRIEVE A THIRD STONE, THE METAL TIP BROKE AND REMAINED INSIDE THE PT. THE PHYSICIAN PLACED AN UNSPECIFIED PLASTIC BILIARY STENT FOR THE DUCT TO REMAIN PATENT AND DRAINING, DESIRING THAT THE METAL TIP WILL DRAIN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC LQC BOSTON SCIENTIFIC M00510880 11289956

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention