BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTICK II

    MDR report key: 2103393 · Received May 11, 2011

    Report

    Report Number
    2103393
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    AFTER INITIAL NEEDLE PUNCTURE FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC), THE TIP OF THE 0.018 WIRE SHEARED OFF IN THE LEFT HEPATIC LOBE. NO MEDICAL CONCERNS. COMPLETION OF THE PROCEDURE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSTICK II ACCUSTICK II INTRODUCER SYSTEM DYB BOSTON SCIENTIFIC CORPORATION M001207040 14151908

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR