BEUDAMED
    FDA Adverse Event Summary report: N

    LIFE PORT

    MDR report key: 36945 · Received September 6, 1996

    Report

    Report Number
    MW1009887
    Date Received
    September 6, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 22, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A CHEST X-RAY ON 8/5/96 WHICH NOTED THAT A FRACTURE HAD OCCURRED THROUGH THE CATHETER WITH A 12.5 CM FRAGMENT OF CATHETER EMBOLIZED INTO THE PULMONARY ARTERY BIFURCATION EXTENDING TO THE LEFT AND RIGHT. CATHETER FRAGMENT WAS REMOVED BY A RADIOLOGIST PER RADIOLOGICAL PROCEDURE ON 8/5/96, REMOVED SURGICALLY ON 8/16/96. ADD'L EXPLANT DATE 8/16/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PORT Implant IMPLANTABLE VENOUS ACCESS DEVICE LJT STRATO/INFUSAID, INC. * 12763

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR