BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 7820781 · Received August 27, 2018

    Report

    Report Number
    3005594788-2018-00002
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    July 27, 2018
    Report Date
    August 27, 2018
    Manufacturer
    XOFT, A SUBSIDARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILURE ANALYSIS CONFIRMED THAT AN OBJECT OF UNKNOWN ORIGIN HAD BREACHED THE EXTERNAL SURFACE OF THE BALLOON TRIGGERING A LONGITUDE TEAR EXTENDING BETWEEN THE PROXIMAL AND DISTAL ENDS OF THE BALLOON. A DEVICE LOT HISTORY REVIEW CONFIRMED NO RELATED ANOMALIES. ALL MANUFACTURING SPECIFICATIONS HAD BEEN MET FOR THE LOT RELEASED. THE INDICATED FAILURE MODE IS AN INHERENT RISK OF THE INTRAOPERATIVE (IORT) PROCEDURE AND CONFORMING WITH THE RISK PROFILE DEFINED FOR THE DEVICE. THE FAILURE RATE FOR BALLOON RUPTURES NOT ATTRIBUTED TO USER ERROR IS (B)(4) BASED ON (B)(4) DEVICES SHIPPED FROM JANUARY 1, 2016 THROUGH JUNE 30, 2018, WHICH ENCOMPASSES THE MANUFACTURING RELEASE DATE OF THE DEVICE LOT REVIEWED.

    Description of Event or Problem · 1

    THE 3-4 CM BALLOON APPLICATOR OF THE BRACHYTHERAPY PROCEDURE FOR A PATIENT UNDERGOING INTRAOPERATIVE RADIATION TREATMENT FOR BREAST CANCER WAS FOUND WITH A LONGITUDE TEAR THAT ENABLED THE SALINE SOLUTION FROM THE BALLOON TO ESCAPE. THE INDICATED FINDING WAS DISCOVERED AFTER RADIATION TREATMENT WAS DELIVERED AND THE BALLOON APPLICATOR EXPLANTED FROM THE PATIENT, THEREFORE INDICATING THAT TWICE THE INDICATED RADIATION DOSE MAY HAVE BEEN DELIVERED. 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
    662209 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 3-4 CM, SPERICAL, PRODUCT CODE: JAD JAD XOFT, A SUBSIDARY OF ICAD, INC. 720340 01710227

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other