BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3624226 · Received December 9, 2013

    Report

    Report Number
    3005594788-2013-00006
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 11, 2013
    Report Date
    December 5, 2013
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    5090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETE DEVICE FAILURE ANALYSIS IS PENDING. SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PT UNDERWENT BRACHYTHERAPY RADIATION TREATMENT FOR BREAST CANCER. DEVICE WAS IMPLANTED ON (B)(6) 2013. WHEN PT RETURNED TO THE PHYSICIAN'S OFFICE ON (B)(6) 2013 TO BEGIN RADIATION TREATMENT, THE BALLOON APPLICATOR WAS FOUND RUPTURED. THE DEVICE WAS EXPLANTED FROM THE PT AND REPLACED WITH A NEW DEVICE. THE RADIATION TREATMENT WAS COMPLETED WITHOUT SUBSEQUENT INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638191 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR JAD XOFT, A SUBSIDIARY OF ICAD, INC. 720340 820896

    Patients

    Seq Age Sex Outcome Treatment
    1 Other