BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARISOURCE FSD COUPLING CATHETERS

    MDR report key: 1426023 · Received July 30, 2009

    Report

    Report Number
    8020711-2009-00006
    Event Type
    Injury
    Date Received
    July 30, 2009
    Report Date
    July 30, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    KXK
    PMA / PMN Number
    K952913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THEY DISCOVERED THE RADIATION EFFECTS IN THREE PTS AT F/U APPOINTMENTS FOR PTS TREATED SINCE 2009. THE CUSTOMER IS REVIEWING THEIR WORK FOR ADDITIONAL PTS THAT MAY BE AFFECTED AND FOLLOWING UP WITH THE PTS AS APPLICABLE. ADDITIONAL FEEDBACK FROM THE CUSTOMER ON PT EFFECTS IS NOT ANTICIPATED. THE CUSTOMER HAS INDICATED THEY WERE AWARE THE FSD COUPLING CATHETER PRODUCT WAS RECOMMENDED FOR SINGLE USE. THE EXACT NUMBER OF USES IS NOT KNOWN, INFO SUGGESTS THE PRODUCT WAS REUSED AN EXCESSIVE AMOUNT OF TIMES.

    Description of Event or Problem · 1

    THE FSD APPLICATOR SET IS INDICATED FOR HIGH DOSE RATE IRRADIATION OF THE UTERUS AND CERVIX. THE CUSTOMER WAS REUSING A SINGLE USE FSD COUPLING CATHETER WHICH CONNECTS THE VARISOURCE FSD APPLICATOR TO THE VARISOURCE AFTERLOADER. THE FSD COUPLING CATHETERS WERE KNOWINGLY REUSED BY THE CUSTOMER WHICH CAN BE DAMAGED BY STERILIZATION AND REUSE. INVESTIGATION HAS DETERMINED THE FSD COUPLING CATHETER CONNECTOR HAS COME LOOSE FROM BEING SUBJECT TO REUSE AND MULTIPLE STERILIZATION CYCLES. THE LOOSE CONNECTOR WILL NOT HOLD A TIGHT CONNECTION BETWEEN THE APPLICATOR AND CATHETER CAUSING THE SOURCE WIRE TO NOT BE AT THE DESIRED AND PLANNED LOCATION. THE SOURCE WILL DWELL IN THE WRONG POSITION WHICH CAUSED THE VULVA RADIATION EFFECTS, AND ALSO INDICATES AN UNDER DOSE TO THE PRESCRIPTION POINT. THE CUSTOMER REPORTED THREE PTS WHICH HAVE PRESENTED WITH VULVA REACTIONS ON THE LEFT SIDE WALL BELOW THE FORNICES WHERE THE OVOIDS ARE PLACED. THE PHYSICIAN INDICATED THAT THE VULVA REACTIONS WERE CONSISTENT WITH HIGH, LOCALIZED RADIATION DOSES PROVIDED BY BRACHYTHERAPY TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE FSD COUPLING CATHETERS BRACHYTHERAPY APPLICATOR KXK VARIAN MEDICAL SYSTEMS, INC AL13123000 F02148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other VARISOURCE FSD APPLICATOR SET| VARISOURCE AFTERLOADER