BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3327444 · Received August 19, 2013

    Report

    Report Number
    3005594788-2013-00004
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    July 30, 2013
    Report Date
    August 13, 2013
    Manufacturer
    XOFT, A SUBSIDIARY ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE ANALYSIS: DEVICE WAS RECEIVED BY THE MANUFACTURER COMPLETELY SEVERED AT THE BALLOON APPLICATOR SHAFT. IT APPEARED THAT THE DEVICE WAS MECHANICALLY PULLED APART AT THE POINT OF SEPARATION. NO EXPLANATION WAS PROVIDED BY THE PHYSICIAN OR THE PT ON WHY THE DEVICE WAS RETURNED IN THIS STATE, OR IF ANY DEFECT LOCATED IN THIS SECTION OF THE DEVICE HAD CONTRIBUTED TO THE INCIDENT. A MICROSCOPIC INSPECTION OF THE FRACTURED SECTIONS FOUND NO MANUFACTURING ANOMALIES. FURTHERMORE, THE BALLOON WAS PRESSURIZED TO FULL VOLUME FOR 24-HOURS AND SHOWED NO INDICATION OF LEAKS. A MANUFACTURING LOT HISTORY REVIEW FOUND NO ANOMALIES RELATED TO THE REPORTED COMPLAINT. BASED ON THE OUTCOME OF THIS INVESTIGATION, NO FAILURE WAS CONFIRMED.

    Description of Event or Problem · 1

    PT UNDERWENT A BRACHYTHERAPY RADIATION PROCEDURE FOR BREAST CANCER. FOLLOWING THE PROCEDURE, THE PT ARRIVED HOME AND CALLED THE PHYSICIAN STATING THAT SHE HEARD THE BALLOON OF THE APPLICATOR DEVICE POP AND FELT FLUID LEAKING OUT. SHE THEN REMOVED THE BANDAGES, AND WHILE DOING SO, THE APPLICATOR DEVICE FELL OUT. THE DEVICE WAS RETURNED TO THE PHYSICIAN'S OFFICE BY THE PT'S SON WITH THE DEVICE BROKE IN HALF AT THE BALLOON APPLICATOR SHAFT WITH THE STYLET STILL INSIDE. THE PT GAVE NO EXPLANATION FOR HOW THE DEVICE WAS BROKE IN HALF. THE PT RETURNED TO THE PHYSICIAN'S OFFICE FOR FOLLOW-UP BUT NO MEDICAL INTERVENTION WAS PERFORMED, NOR DID THE PT SUSTAIN ANY SERIOUS INJURY FROM THE INCIDENT. IN A SUBSEQUENT INTERVIEW, IT WAS STATED BY THE PHYSICIAN THAT THE PT WAS NOT IN RISK OF ANY HARM. IT WAS ALSO MENTIONED THAT THE PT WAS IN AN ADVANCED STATE OF DEMENTIA MAKING HER NOT A GOOD CANDIDATE FOR THE PROCEDURE. THE PHYSICIAN AND THE PT DECIDED TO NOT CONTINUE THE PROCEDURE. NOTE: NO PT INJURY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399377 ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR JAD XOFT, A SUBSIDIARY ICAD, INC. 720332 820739

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other