BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 4093275 · Received September 16, 2014

    Report

    Report Number
    3005594788-2014-00004
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 15, 2014
    Manufacturer
    XOFT, A SUBSIDARY OF ICAD
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS OF THE DEVICE FOUND THAT THE BALLOON HAD A LONGITUDAL TEAR ALONG THE SEAM OF THE BALLOON WHERE THE MOLD PARTING LINE EXISTS. THE MOLD PARTING LINE IS FORMED BY THE FABRICATION PROCESS OF THE BALLOON AND IS NOT A MANUFACTURING DEFECT OF THE PROCESS. THERE WAS NO EVIDENCE OF ANY CONTAMINANT PARTICLES OR TOOLING DAMAGE THAT MIGHT HAVE CONTRIBUTED TO THE BALLOON SEPARATING IN THIS AREA. A LOT HISTORY REVIEW FOUND NO ANOMALIES OF POSSIBLE CONSEQUENCE TO THIS INCIDENT. ALL PRODUCT MANUFACTURED FOR THE LOT COMPLIED WITH SPECIFICATIONS FOR PRODUCT RELEASE. MANUFACTURING LOT INVESTIGATED: 820714. XOFT INTERNAL COMPLAINT TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN APBI (ACCELERATED PARTIAL BREAST RADIATION) PROCEDURE FOR BREAST CANCER ON FRIDAY, (B)(6) 2014. THE BALLOON APPLICATOR DEVICE WAS IMPLANTED IN THE PATIENT. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE ON MONDAY, (B)(6) 2014 FOR THE CONTINUATION OF THE APBI PROCEDURE, AT WHICH TIME, THE BALLOON WAS FOUND IN A RUPTURED STATE. THE BALLOON WAS REMOVED FROM THE PATIENT ON (B)(6) 2014 AND A REPLACEMENT BALLOON WAS IMPLANTED. THE APBI PROCEDURE WAS COMPLETED AND THE PATIENT SUSTAINED NO INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571608 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 3-4 CM JAD XOFT, A SUBSIDARY OF ICAD 720340 820714

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention