BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VTX VASCULAR ACCESS SYSTEM

    MDR report key: 841940 · Received April 19, 2007

    Report

    Report Number
    MW1042652
    Event Type
    Injury
    Date Received
    April 19, 2007
    Date of Event
    March 9, 2007
    Report Date
    April 19, 2007
    Manufacturer
    ANGIO DYNAMICS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIFEPORT VASCULAR ACCESS PORT CAT # LVTX7513 FROM RITA MEDICAL SYSTEMS/ANGIO DYNAMICS INC. IMPLANTED IN 2007. SATISFACTORY PLACEMENT CONFIRMED BY X-RAY. TWO MONTHS LATER, X-RAY SHOWED THE DISTAL 6-7 CM OF THE CATHETER WAS BROKEN OFF AND LOCATED IN THE RIGHT VENTRICLE PULMONARY OUTFLOW TRACT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSP FOR REMOVAL OF DETACHED PORTION OF THE CATHETER. THE CATHETER PORTION WAS REMOVED VIA PERCUTANEOUS LETOCATHETER. THIRTEEN DAYS LATER, THE REMAINING PORTION OF THE DEVICE WAS REMOVED. THE MFR - ANGIO DYNAMICS - WAS NOTIFIED AND DEVICE WAS SENT TO THEM. AT THAT TIME ANOTHER PORT WAS INSERTED ON THE RIGHT SIDE USING LIFEPORT PORT CATALOG NUMBER LVTX7513, LOT NUMBER 29207. DETACHMENT OF CATHETER PORTION OF PORT DEVICE AND MIGRATION OF DETACHED CATHETER TO THE RIGHT VENTRICLE AND PULMONARY ARTERY OUTFLOW TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VTX VASCULAR ACCESS SYSTEM VITAPORT LJT ANGIO DYNAMICS LVTX 7513 28843

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability