BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3349807 · Received August 26, 2013

    Report

    Report Number
    3005594788-2013-00005
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 26, 2013
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAN, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE ANALYSIS: THE BALLOON OF THE DEVICE HAD A LONGITUDINAL TEAR ALONG THE SEAM OR MOLD PARTING LINE. THE FAILURE MODE IS OF THE SAME FAILURE SIGNATURE AS THE BALLOON FAILURES OF PREVIOUS MDR CUSTOMER COMPLAINTS FILED UNDER THE FOLLOWING REPORT NUMBERS: 3005594788-2013-00001, 3005594788-2013-00002. CORRECTIVE ACTION WAS INITIATED TO EFFECT SEVERAL IMPROVEMENTS IN THE MANUFACTURER'S PROCESS TO REDUCE THE OCCURRENCE OF THE BALLOON FAILURES IN THE FIELD. AN INVESTIGATION OF THE LOT HISTORY RECORD FOR THE SUSPECT PART CONFIRMED THAT THE ASSOCIATED LOT WAS PRODUCED IN DECEMBER 2011 AND PREDATED THE IMPLEMENTATION OF THE PROCESS REFINEMENTS EFFECTED IN 2013 BY THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT BRACHYTHERAPY RADIATION TREATMENT FOR BREAST CANCER. WHILE IN ROUTE TO THE PATIENT'S HOME, THE IMPLANTED BALLOON HAD RUPTURED. PATIENT RETURNED TO THE PHYSICIAN'S OFFICE WHERE THE PHYSICIAN REPLACED THE RUPTURED 3-4 CM SIZED BALLOON WITH A 4-5 CM SIZE BALLOON. IT WAS OBSERVED THAT THE BALLOON HAD SPLIT ALONG ITS SIDE. NO SERIOUS INJURY WAS SUSTAINED BY THE PATIENT, AND THE PATIENT RETURNED HOME AFTER THE BALLOON WAS REPLACED WITH NO FURTHER INCIDENT. INTERNAL TRACKING NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415880 ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR JAD XOFT, A SUBSIDIARY OF ICAN, INC. 720340 820626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other