BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARISOURCE

    MDR report key: 1514600 · Received October 16, 2009

    Report

    Report Number
    8020711-2009-00008
    Event Type
    Other
    Date Received
    October 16, 2009
    Date of Event
    September 21, 2009
    Report Date
    October 16, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K071467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WIRE DRAFT ERROR INDICATES UNINTENDED WIRE MOVEMENT DURING THE TREATMENT. THIS MAY IN SOME WAY BE RELATED TO PATIENT MOVEMENT. HOWEVER, IT IS NOT EXPECTED THAT THIS WAS THE MAIN CAUSE OF THE STUCK WIRE IN THE CATHETER. THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. BY SUBMITTING THIS REPORT, THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE, OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

    Description of Event or Problem · 1

    AT APPROXIMATELY 5:00P.M. (B) (6) ON (B) (6), THE (B) (6) CONTACTED VARIAN MEDICAL SYSTEMS, INC. AND REPORTED THAT AN IR-192 HDR SOURCE ((B) (4)) WAS STUCK OUT DURING A PATIENT TREATMENT. THIS OCCURRED DURING THE 8TH FRACTION OF A 10 FRACTION PLAN, AS THE SOURCE WAS MOVING FROM THE 2ND TO 3RD DWELL POSITION. THE APPLICATOR IN USE, A (B) (4) MAMMOSITE APPLICATOR AND THE RADIATION SOURCE WERE TOGETHER REMOVED FROM THE PATIENT'S BREAST AND PLACED IN THE EMERGENCY SHIELDED CONTAINER WITH THE TAIL OF THE SOURCE WIRE STILL INSTALLED IN THE AFTERLOADER UNIT. THE PATIENT WAS REMOVED FROM THE TREATMENT ROOM AND SURVEYED. THE ROOM WAS EVACUATED AND SECURED. VARIAN'S RADIATION SAFETY OFFICER WAS NOTIFIED IMMEDIATELY AND TWO VARIAN FIELD SERVICE ENGINEERS WERE DISPATCHED TO THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other