BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX PORT

    MDR report key: 1190216 · Received October 6, 2008

    Report

    Report Number
    MW5008557
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    RITA MEDICAL SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RETRIEVAL OF FRACTURED CATHETER UTILIZING LOOP SNARE. PORT IMPLANTED AT ANOTHER FACILITY APPROX A YEAR AGO PER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX PORT INFUSAPORT LJT RITA MEDICAL SYSTEMS 942641

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other