BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARISOURCE

    MDR report key: 1667612 · Received April 23, 2010

    Report

    Report Number
    8020711-2010-00005
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    April 23, 2009
    Report Date
    April 21, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
    Product Code
    JAQ
    PMA / PMN Number
    K061582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT WAS CAUSED BY USER ERROR AND DEVICE EVAL IS NOT APPLICABLE. THIS INCIDENT IS (B) (4). VARIAN MEDICAL SYSTEMS, INC. BECAME AWARE OF THE ADVERSE EVENT THROUGH POST MARKET SURVEILLANCE ACTIVITIES WHEN REVIEWING (B) (6). THE CUSTOMER HAD NOT PREVIOUSLY CONTACTED VARIAN MEDICAL SYSTEMS. FOLLOW-UP ON THIS EVENT WITH THE CUSTOMER SITE CONFIRMED, THE ERROR WAS "TOTALLY USER ERROR" IN THE MEASURED DISTANCE RECORDED. THE VARIOSOURCE AFTERLOADER DEVICE NEITHER CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE (B) (6) INCLUDED A REPORTED EVENT INVOLVING A MAMMOSITE MISTREATMENT. EVAL OF THIS INCIDENT FOUND IT WAS RELATED TO (B) (6). THE INFO AVAILABLE IN THE (B) (6) STATED A FEMALE PT WAS TO RECEIVE HDR TWICE A DAY FOR A TOTAL OF 10 TREATMENTS WITH AN EXPECTED DOSE OF 34GY VIA MAMMOSITE TREATMENT. A DUMMY WIRE WAS INSERTED INTO THE BALLOON TO CHECK AND MEASURE THE TUBE LENGTH FOR DOSAGE CALCULATIONS. A CT SCAN WAS PERFORMED DAILY TO VERIFY THE POSITION OF THE TREATMENT SITE. TREATMENT CALCULATIONS WERE DONE, REVIEWED, APPROVED, AND TREATMENT BEGAN ON (B) (6), 2009. ON (B) (6), 2009, A DIFFERENT THERAPY PHYSICIST WAS CHECKING THE PT'S CHARTS AND DISCOVERED THAT THERE HAD BEEN AN ERROR IN THE PLACEMENT OF THE SOURCE DURING THE TREATMENT. SUBSEQUENT REVIEW CONFIRMED, THE SOURCE WAS NOT FULLY INSERTED INTO THE BALLOON, BUT WAS 3CM FROM WHERE IT SHOULD HAVE BEEN, THEREBY RESULTING NOT ONLY IN A LARGE DIFFERENCE IN THE TUMOR DOSE RECEIVED (30% OF INTENDED), BUT ALSO IN A SEVER DOSAGE TO NON-INTENDED AREAS OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE BRACHYTHERAPY SYST. REMOTE AFTERLOADER JAQ VARIAN MEDICAL SYSTEMS INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other