BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE RADIATION THERAPY SYSTEM

    MDR report key: 1266142 · Received December 5, 2008

    Report

    Report Number
    MW5009259
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    December 3, 2008
    Report Date
    December 5, 2008
    Manufacturer
    CYTYC-HOLOGIC
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MAMMOSITE HDR TREATMENT BALLOON THAT WAS PLACED IN LATE 2008 WOULD NOT ALLOW THE HDR SOURCE TO PASS THROUGH THE CATHETER LUMEN THE NEXT DAY. THE HDR RADIOACTIVE SOURCE COULD NOT PASS BEYOND THE 2 CMS POINT IN THE MAMMOSITE BALLOON CATHETER. AFTER NUMEROUS ATTEMPTS TO CLEAR THE OBSTRUCTION WITHOUT SUCCESS, WE STOPPED. THE PATIENT WAS GIVEN THE OPTION OF HAVING A 4TH MAMMOSITE BALLOON CATHETER PLACED, WHICH SHE DECLINED. THE OBSTRUCTED MAMMOSITE HDR BALLOON CATHETER WAS REMOVED THE SAME DAY. THE MAMMOSITE HDR BALLOON CATHETER WAS PLACED BY AND AT THE OFFICE DR THIS CAUSED A TREATMENT DELAY FOR BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE RADIATION THERAPY SYSTEM MAMMOSITE JAQ CYTYC-HOLOGIC SPHERICAL 4-5 CM 08F21HA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other