BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 9148260 · Received October 2, 2019

    Report

    Report Number
    3005594788-2019-00001
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 2, 2019
    Manufacturer
    XOFT, A SUBSIDARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 3-4 CM BALLOON APPLICATOR OF THE BRACHYTHERAPY PROCEDURE FOR A PATIENT UNDERGOING INTRAOPERATIVE RADIATION TREATMENT FOR BREST CANCER WAS FOUND TO HAVE LEAKED. 45CC'S OF INFLATION FLUID WAS PUT INTO THE BALLOON AND 30CC'S WERE REMOVED POST SURGERY. THE DISCREPANCY RESULTED IN AN INCORRECT DOSE BEING ADMINISTERED TO THE BREAST IORT PATIENT. THE PROCEDURE WAS COMPLETED AND NO APPARENT INJURY WAS SUSTAINED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. COMPLAINT TRACKING # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942619 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 3-4 CM, SPERICAL JAD XOFT, A SUBSIDARY OF ICAD, INC. 720788 01802009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other