BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEGMENTED CYLINDER APPLICATOR SET

    MDR report key: 2625752 · Received June 15, 2012

    Report

    Report Number
    9612638-2012-00009
    Event Type
    Other
    Date Received
    June 15, 2012
    Date of Event
    November 18, 2011
    Report Date
    May 21, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K983436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER DID NOT FOLLOW INSTRUCTIONS FOR USE AS THEY REPORTED THAT THE CLAMPING NUT FOR THE GUIDE TUBE WAS NOT TIGHTEN ENOUGH TO HOLD THE FLEXIBLE PROBE IN POSITION. THEREFORE THE FLEXIBLE PROBE SLIPPED OUT OF THE VAGINAL CYLINDER, WHICH RESULTED IN THE MISPOSITIONING OF THE RADIATION SOURCE. USER DID NOT FOLLOW INSTRUCTIONS FOR USE AS THEY USED PT THIGHS CLOSED AROUND THE CYLINDER AND GUIDING TUBE TO SECURE THE DEVICE DURING TREATMENT POSITION, RATHER THAN ADD'L ACCESSORIES AS DESCRIBED IN THE INSTRUCTION FOR USE. NO FURTHER F/U OF THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY USED A SEGMENTED CYLINDER APPLICATOR SET FOR THE LAST FRACTION OF A BRACHYTHERAPY TREATMENT ON (B)(6) 2011. AT THE TIME OF TREATMENT NO ABNORMAL CIRCUMSTANCE WAS NOTED FOR THAT TREATMENT FRACTION DURING OR AFTER TREATMENT. DURING THE PT'S F/U APPOINTMENT ON (B)(6) 2011, THE PHYSICIAN NOTED A REACTION ON THE LABIA BUT WASN'T SURE WHAT IT WAS AND APPARENTLY DIDN'T FEEL THAT IT WAS A RADIATION INDUCED REACTION. ON (B)(6) 2012, THEY REC'D A CALL FROM ANOTHER PHYSICIAN (DIFFERENT CLINIC) REPORTING THAT THE PT IS EXPERIENCING LATE STAGE TISSUE NECROSIS TO BOTH RIGHT AND LEFT INNER THIGHS. USING A PHOTOGRAPH PROVIDED BY ANOTHER PHYSICIAN, THE CLINICAL TEAM DETERMINED THAT IT IS LIKELY THE PROBE SLIPPED APPROX 15 CM PRIOR TO DELIVERY OF THE RADIATION FOR THE LAST FRACTION. THE LENGTH OF THE SKIN REACTION WAS ESTIMATED TO BE APPROX 7 CM CORRESPONDING TO THE ACTIVE LENGTH DELIVERED 15 CM PROXIMAL TO THE INTENDED LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGMENTED CYLINDER APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other