BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 9434446 · Received December 6, 2019

    Report

    Report Number
    3005594788-2019-00002
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    XOFT, A SUBSIDARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS TESTED PER NORMAL REQUIREMENTS AND SHOWED NO SIGNS OF LEAKAGE OR ASYMMETRY. THE SUTURES WERE PLACED AND LEFT IN A LOOSE MANOR, THE BALLOON WAS THEN PLACED IN TO THE CAVITY AND FILLED TO 30CC. THE SUTURES WERE THEN TIGHTENED AND THE BALLOON WAS IMAGED TO VERIFY THE SKIN BRIDGE WHICH WAS GREATER THAN 1CM. AT THE TIME OF IMAGING, THE BALLOON APPEARED TO BE IN GOOD CONDITION. THE TREATMENT WAS DELIVERED PER PROTOCOL. THE SALINE IN THE BALLOON IS WITHDRAWN BY THE SURGEON, AND WAS NOT MEASURED, BUT CLEARLY NOT 30CC. THE RADIATION ONCOLOGIST INDICATED THAT THE SURGEON DID NOT NOTICE ANY SALINE POOLED IN THE CAVITY. THE BALLOON WAS EVALUATED AND CONFIRMED LEAKAGE, BUT HAS BEEN SENT TO MATERIAL SUPPLIER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE 3-4 CM BALLOON APPLICATOR OF THE BRACHYTHERAPY PROCEDURE FOR A PATIENT UNDERGOING INTRAOPERATIVE RADIATION TREATMENT FOR BREAST CANCER WAS FOUND WITH A PIN HOLE THAT ALLOWED THE SALINE SOLUTION FROM THE BALLOON TO ESCAPE. THE INDICATED FINDING WAS DISCOVERED AFTER RADIATION TREATMENT WAS DELIVERED AND THE BALLOON APPLICATOR EXPLANTED FROM THE PATIENT, THEREFORE INDICATING THAT SALINE SOLUTION HAD LEAKED DURING THE TREATMENT. COMPLAINT TRACKING # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228841 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLON APPLICATOR, SIZE 3-4 CM, SPHERICAL, PRODUCT CODE JAD, PRODUCT CODE: IYC JAD XOFT, A SUBSIDARY OF ICAD, INC. 720788 01708034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other