BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOSITE

    MDR report key: 752461 · Received August 10, 2005

    Report

    Report Number
    MW1036309
    Event Type
    Injury
    Date Received
    August 10, 2005
    Date of Event
    June 20, 2003
    Report Date
    August 10, 2005
    Manufacturer
    PROXIMA THERAPEUTICS
    Product Code
    JAQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT IS DIAGNOSED WITH DUCTAL CARCINOMA IN SITU OF THE RIGHT BREAST. THE PATIENT INITIALLY DESIRED BILATERAL MASTECTOMIES WITH RECONSTRUCTION. SHE ELECTED TO PURSUE THIS OPTION BECAUSE OF HER UNWILLINGNESS TO UNDERGO A SIX WEEK COURSE OF RADIATION THERAPY AS PART OF A CONSERVATIVE MANAGEMENT PLAN. THE PATIENT WAS PRESENTED WITH THE OPTION OF MAMMOSITE THERAPY AND ITS COMPRESSED TREATMENT TIME AND CONSENTED TO THERAPY. THE MAMMOSITE DEVICE WAS PLACED AND CT IMAGING SHOWED THE BALLOON TO BE 4.99MM FROM THE SKIN SURFACE. MANUFACTURER INSTRUCTIONS INDICATE 5MM TO BE A "SAFE" DISTANCE. THE CATHETER WAS SUBSEQUENTLY LOADED WITH A HIGH DOSE RATE RADIATION SOURCE DELIVERING 340 CGY TO 1CM AWAY FROM THE BALLOON SURFACE TWICE A DAY FOR TEN TREATMENTS. THE LAST DAY OF TREATMENT WAS A WEEK LATER. WITHIN THREE WEEKS THE PATIENT HAD EVIDENCE OF NECROSIS OF THE SKIN OVERLYING THE BALLOON SURFACE. OVER THE MONTHS FOLLOWING MAMMOSITE TREATMENT, THE PATIENT WENT ON TO DEVELOP A CHRONIC, NON-HEALING, DRAINING WOUND. ULTIMATELY THE PATIENT REQUIRED A COMPLICATED WIDE LOCAL EXCISION OF THE NECROTIC BREAST TISSUE WITH SKIN FLAP CLOSURE. THE REMAINING SKIN HAS SIGNIFICANT TELANGIECTATIC CHANGE, CONSISTENT WITH HIGH DOSE RADIATION EXPOSURE, AND AN OVERALL POOR COSMETIC RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE BALLOON CATHETER DEVICE FOR RADIATION AFTERLOADING JAQ PROXIMA THERAPEUTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R MANUFACTURER RECOMMENDATIONS WITH A HIGH DOSE| RATE RADIATION SOURCE, DELIVERING 340 CGY TO 1 CM| OF 34000 CGY IN FIVE DAYS.| DAY X TEN TREATMENTS, FOR A TOTAL| FROM THE BALLOON SURFACE TWICE A| AS PREVIOUS, THE MAMMOSITE WAS LOADED PER