BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM

    MDR report key: 2809715 · Received October 22, 2012

    Report

    Report Number
    3005520039-2012-00001
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    April 16, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ISORAY MEDICAL, INC
    Product Code
    KXK
    PMA / PMN Number
    K111931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GLIASITE RADIATION THERAPY SYSTEM DID NOT MALFUNCTION. THE DEVICE WAS USED IN ACCORDANCE WITH PRODUCT LABELING. THE PHYSICIAN FEELS THIS IS A WELL-KNOWN TOXICITY. RADIATION NECROSIS IS A KNOWN SIDE EFFECT OF RADIATION THERAPY. THE GLIASITE CATHETER MODEL 1040 USED HAD AN EXP DATE OF 10/31/2012 AND CAME FROM LOT GC11-003. THE GLIASITE IOTREX (RADIOTHERAPY SOLUTION) MODEL 8150 USED HAD AN EXP DATE OF 05/04/2012 AND CAME FROM LOT I120404-7.

    Description of Event or Problem · 1

    PT HAD A 4CM GLIASITE CATHETER MODEL # 1040 IMPLANTED ON (B)(6) 2012, AND BRACHYTHERAPY SUCCESSFULLY DELIVERED 20 DAYS LATER FOR APPROXIMATELY 4 DAYS. APPROXIMATELY 7 MONTHS LATER PT PRESENTED WITH RADIATION NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM KXK ISORAY MEDICAL, INC 1040 / 8150 GC11-003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PT WAS TREATED WITH TEMODAR AND EXTERNAL BEAM| RADIATION.| PT UNDERWENT SURGERY FOR RESECTION GRADE 3-4 TUMOR