BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 5186251 · Received October 28, 2015

    Report

    Report Number
    3005594788-2015-00001
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 17, 2015
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE FAILURE ANALYSIS COULD NOT BE PERFORMED, AS THE DEVICE WAS DISCARDED BY THE HOSPITAL FOLLOWING THE PROCEDURE. THE MANUFACTURER (XOFT) PERFORMED A LOT HISTORY REVIEW ON 10/21/2015 AND FOUND NO ANOMALIES RELATING TO THE REPORTED EVENT. ALL SPECIFICATIONS FOR THE MANUFACTURING OF THE DEVICE HAD BEEN MET. THE DEVICE IFU (INSTRUCTIONS FOR USE) APPROPRIATELY DOCUMENTED THE PRECAUTIONARY INSTRUCTIONS ALERTING THE USER OF THE DEVICE TO NOT USE SHARP INSTRUMENTS (I.E., SYRINGES, FORCEPS, ETC.) IN THE VICINITY OF THE BALLOON. NO FURTHER ACTION WAS TAKEN FOR THE INVESTIGATION OF THIS COMPLAINT.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT BRACHYTHERAPY TREATMENT FOR BREAST CANCER. THE 3-4 CM BALLOON APPLICATOR OF THE BRACHYTHERAPY TREATMENT SYSTEM WAS INSERTED IN THE PATIENT'S BREAST TO INITIATE THE PROCEDURE. WHILE THE BALLOON WAS INSERTED, THE PHYSICIAN INJECTED A DOSE OF LIDOCAINE IN THE AREA OF THE BALLOON INSERTION. AFTER THE THERAPEUTIC DOSE OF RADIATION WAS DELIVERED, THE BALLOON WAS EXTRACTED FROM THE CAVITY OF THE PATIENT, AT WHICH POINT IT WAS OBSERVED THAT ONLY 5 CC OF SALINE WAS PRESENT IN THE BALLOON WHEN 30 CC OF SALINE HAD ORIGINALLY FILLED THE DEVICE. THE TREATING FACILITY STATED THAT THE BALLOON MIGHT HAVE BEEN PUNCTURED BY THE SYRINGE DURING THE INJECTION, THUS DECREASING THE VOLUME OF THE BALLOON EXPANDING THE PATIENT'S CAVITY AND POSSIBLY EXPOSING THE PATIENT TO A HIGHER DOSE OF RADIATION TREATMENT. THE PHYSICIAN RE-SECTIONED THE AFFECTED AREA OF THE PATIENT AS A PRECAUTIONARY MEASURE. THE PATIENT EXPERIENCED NO ADVERSE SYMPTOMS FOLLOWING THE PROCEDURE AND WAS SUBSEQUENTLY RELEASED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713497 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 3 - 4 CM SPERICAL JAD XOFT, A SUBSIDIARY OF ICAD, INC. 720342 503485

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other