BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RÖSCH-UCHIDA

    MDR report key: 1676157 · Received April 30, 2010

    Report

    Report Number
    1676157
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 30, 2010
    Manufacturer
    COOK MEDICAL
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT)PROCEDURE, THE SHEATH FRAYED AND BECAME LODGED IN A VEIN IN THE PATIENT'S CHEST. CHEST X-RAY INDICATES FOREIGN BODY. TINY RING-LIKE OPACITY PROJECTED OVER THE RIGHT SIDE OF THE MEDIASTINUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RÖSCH-UCHIDA SET, BIOPSY GBZ COOK MEDICAL * 2476262

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR