BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARISOURCE IX HDR BRACHYTHERAPY AFTERLOADER

    MDR report key: 1993049 · Received February 7, 2011

    Report

    Report Number
    8020711-2011-00001
    Event Type
    Other
    Date Received
    February 7, 2011
    Date of Event
    June 10, 2010
    Report Date
    January 14, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K071467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO VARIAN DEVICE MALFUNCTIONED. THE ROOT CAUSE WAS IDENTIFIED AS INCORRECT TREATMENT LENGTH DUE TO THE SELECTION OF INCORRECT TRANSFER GUIDE TUBES BY THE USER. USER ERROR OCCURRED WITH REGARD TO THE CONFIGURATION OF THE OVERALL APPLICATOR LENGTH. THE USER CONFIGURED A STANDARD TREATMENT LENGTH OF 132.0 CM BUT PRESCRIBED, IN THE SYSTEM, THAT THE TREATMENT LENGTH WAS ONLY 120.0 CM. THE THERAPIST ASSISTING WITH PATIENT TREATMENT WAS THE SAME WHO PERFORMED THE SIMULATION AND SELECTED/PULLED THE SAME (INCORRECT) TRANSFER GUIDE TUBE FOR TREATMENT AS USED FOR SIMULATION. THE PHYSICIST DID NOT REVIEW THE SIMULATION WORKSHEET DURING PLAN SECOND CHECK OR PRIOR TO PT TREATMENT AND THE LENGTH OF 132.0 CM WAS OVERLOOKED AGAIN. THE UNDER-DOSES TO THE TARGET AREAS (VAGINAS) AND UNINTENDED EXPOSURE TO THE THIGHS, WERE IDENTIFIED BY THE RADIATION ONCOLOGIST AND MEDICAL PHYSICIST AT THE SITE. NO ADDITIONAL MEDICAL PROFESSIONAL WAS CONSULTED. THE PATIENTS PRESENTED WITH SKIN IRRITATION DURING ROUTINE, FOLLOW UP APPOINTMENTS. THE SKIN IRRITATION IN ALL FOUR PATIENTS HAS SINCE RESOLVED AND NO FURTHER PROBLEMS HAVE BEEN REPORTED. THIS EVENT HAS BEEN REPORTED TO THE NRC BY THE SITE WHERE THE EVENTS OCCURRED. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    FOUR PATIENTS RECEIVED VAGINAL CYLINDER TREATMENTS (BETWEEN (B)(6) 2010), WITH INCORRECT TREATMENT LENGTHS. THE TREATMENT LENGTHS PER DEPARTMENT PROTOCOL AND INTENDED TO BE USED FOR THE BRACHYVISION TREATMENT PLANS WAS 120.0 CM. THE TOTAL LENGTH OF TRANSFER GUIDE TUBE + SEGMENTED CYLINDER WAS 132.0 CM (AFTER 1.4 CM WAS SUBTRACTED FROM MEASURED LENGTH). THEREFORE, TREATMENT WAS DELIVERED 12.0 CM PROXIMAL OF INTENDED SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE IX HDR BRACHYTHERAPY AFTERLOADER SYS, APPLICATOR, RADIONUCLIDE, R-C JAQ VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS H60

    Patients

    Seq Age Sex Outcome Treatment
    1