BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GILASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 744160 · Received July 31, 2006

    Report

    Report Number
    1067103-2006-00004
    Event Type
    Injury
    Date Received
    July 31, 2006
    Date of Event
    March 21, 2005
    Report Date
    March 21, 2005
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    IWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEWED - NO EVIDENCE OF PRODUCT STERILIZATION ISSUES. DEVICE WAS NOT RETURNED FOR EVALUATION. INFECTION IS AN ANTICIPATED ADVERSE EVENT ASSOCIATED WITH CRANIAL BRACHYTHERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLIASITE BALOON CATHETER WA EXPLANTED AND IOTREX RADIOTHERAPY SOLUTION WAS RETRIEVED 29 HOURS PRIOR TO THE COMPLETION OF BRACHYTHERAPY. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE GLIASITE CATHETER 3/10/2005. PATIENT WAS ADMITTED TO HOSPITAL 03/20/2005 AFTER DIAGNOSIS OF SEPSIS DUE TO INFECTION. PATIENT EVALUATED BY NEUROSURGEON AND RADIATION ONCOLOGIST (RO). RO REPORTED RADIATION IN THE BLADDER. ON 03/21/2005, DEVICE WAS EXPLANTED AND IOTREX WAS RETRIEVED IN THE OPERATING ROOM UNDER ANESTHESIA BECAUSE OF PATIENT DISCOMFORT CAUSED BY THE INFECTION. IOTREX WAS RETRIEVED AT 6:15PM; HOWEVER, RADIATION WAS NOT RECORDED IN THE BLADDER AT 4:30PM POST-RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GILASITE RADIATION THERAPY SYSTEM (RTS) MANUAL RADIONUCLIDE APPLICATOR IWJ CYTYC SURGICAL PRODUCTS * M22417

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R