BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3810914 · Received March 23, 2014

    Report

    Report Number
    3005594788-2014-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 21, 2014
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS OF THE DEVICE FOUND A SMALL CUT IN THE SHAFT NEAR THE LOCATION OF THE HUB. THE CUT APPEARED TO BE ATTRIBUTED TO A SHARP TOOL, AND THE DEVICE LEAKED IN THIS AREA OF THE CUT. A DEVICE LOT HISTORY REVIEW CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND THAT THERE WERE NO ANOMALIES OF THE LOT INDICATIVE OF THE DEVICE FAILURE. FURTHERMORE, AS PART OF THE APBI PROCEDURE, THE DEVICE IS VERIFIED FOR CORRECT PLACEMENT AND SUSTAINMENT OF PRESSURE. THE DEVICE LEAK WAS FOUND SEVERAL DAYS AFTER IMPLANT. BASED ON THE COMPILATION OF THESE FINDINGS IT IS REASONED THAT THE DEVICE FAILURE IS ATTRIBUTABLE TO USE ERROR. INTERNAL COMPLAINT TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN APBI (ACCELERATED PARTIAL BREAST IRRADIATION) PROCEDURE FOR BREAST CANCER. THE BALLOON APPLICATOR PLACED IN THE PATIENT WAS FOUND DEFLATED SEVERAL DAYS AFTER THE DEVICE WAS PLACED. AN EVALUATION OF THE DEVICE FUND THAT IT WOULD NOT HOLD PRESSURE AND LEAKED. A NEW DEVICE WAS PLACED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO INJURY WAS SUSTAINED BY THE PATIENT AS AN OUTCOME OF THIS EVENT. INTERNAL COMPLAINT TRACKING NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171115 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR JAD XOFT, A SUBSIDIARY OF ICAD, INC. 720340 820908

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention