BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 748648 · Received July 31, 2006

    Report

    Report Number
    1067103-2005-00006
    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, US
    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. CYTYC SURGICAL PRODUCTS IS RESUBMITTING MDR FORM 3500A TO CORRECT TYPOGRAPHICAL ERROR IN THE MFR REPORT # 1067103-2005-00006. FORM 3500A WAS SUBMITTED TO FDA ON 8/29/05. THE EVENT, NARRATIVE AND CONCLUSION DOES NOT CHANGE. THE CORRECTION BEING SUBMITTED IS THE MFR REPORT # ON PAGE 1 OF FORM 3500 A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLIASITE BALLOON CATHETER WAS EXPLANTED AND IOTREX RADIOTHERAPY SOLUTION WAS RETRIEVED 29 HRS PRIOR TO THE COMPLETION OF BRACHYTHERAPY. IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH THE GLIASITE CATHETER IN 2005. PT WAS ADMITTED TO HOSP 10 DAYS AFTER DIAGNOSIS OF SEPSIS DUE TO INFECTION. PT EVALUATED BY NEUROSURGEON AND RADIATION ONCOLOGIST (RO). RO REPORTED RADIATION IN THE BLADDER. ON THE FOLLOWING DAY, DEVICE WAS EXPLANTED AND IOTREX WAS RETRIEVED IN THE OPERATING ROOM UNDER ANESTHESIA BECAUSE OF PT 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 GLIASITE RADIATION THERAPY SYSTEM (RTS) MANUAL RADIONUCLIDE APPLICATOR IWJ CYTYC SURGICAL PRODUCTS * M22417

    Patients

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