BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI CATHETER 6-1

    MDR report key: 3603317 · Received January 29, 2014

    Report

    Report Number
    MW5034134
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 28, 2014
    Manufacturer
    CIANNA MEDICAL
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A SAVI APPLICATOR USED FOR ACCELERATED PARTIAL BREAST IRRADIATION MALFUNCTIONED ALLOWING FLUID TO LEAK INTO ONE OF THE HIGH DOSE RATE (HDR) IRIDIUM-192 (IR192) SOURCE CHANNELS. BECAUSE OF THE LEAK THAT CHANNEL WAS NOT USED FOR THE TREATMENT. THE FLUID IF ALLOWED TO COME IN CONTACT WITH THE HDR IR192 SOURCE CAN CAUSE DAMAGE TO THE HDR UNIT AND POTENTIALLY THE IR192 SOURCE SUCH THAT IT COULD SHEAR OFF DUE TO RUST FORMATION. IF THE FLUID CONTAMINATES THE HDR UNIT, IT COULD CAUSE DELAY IN TREATMENT FOR THE PT AS WELL AS OTHER HDR PTS WHILE THE UNIT IS REBUILT AND THE SOURCE PREMATURELY EXCHANGED. THE DESIRED TREATMENT VOLUME AND DOSE WERE ACHIEVED USING THE REMAINING CHANNELS. DATES OF USE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62581 SAVI CATHETER 6-1 BREAST CATHETER JAQ CIANNA MEDICAL SAVI 6-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other