BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 498493 · Received November 26, 2003

    Report

    Report Number
    75369-2003-00026
    Event Type
    Injury
    Date Received
    November 26, 2003
    Date of Event
    November 18, 2003
    Report Date
    November 20, 2003
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2003, PATIENT HAD GLIASITE PLACED AND RECEIVED BRACHYTHERAPY 17 DAYS LATER. THE DEVICE WAS REMOVED 7 DAYS LATER. PATIENT WAS HOSPITALIZED 3 MONTHS LATER TO HAVE A SHUNT PLACED TO RELIEVE SYMPTOMS OF SHORT-TERM MEMORY AND MILD GAIT DISTURBANCE. AFTER SHUNT PLACEMENT, KPS RETURNED TO 100%. NINE DAYS LATER, PATIENT WAS ADMITTED TO HOSPITAL FOR SHORTNESS OF BREATH AND CT SHOWED PULMONARY EMBOLISM WITHIN RIGHT LOWER LOBE OF PULMONARY ARTERY AND SEGMENTAL EMBOLI WITHIN LEFT LOWER LOBE. NO PLEURAL EFFUSIONS WERE SEEN AND PATIENT WAS ABLE TO MAINTAIN OXYGENATION. PATIENT STARTED ON HEPARIN WITH PLANNED SWITCH TO COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM (RTS) BALLOON CATHETER, MANUAL RADIONUCLIDE APPLICATOR KXK PROXIMA THERAPEUTICS, INC. * M20527

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization HEPARIN (UNK TO UNK).