BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 8282885 · Received January 28, 2019

    Report

    Report Number
    3005594788-2018-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    December 28, 2018
    Report Date
    February 28, 2019
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ENHANCED IMAGING ANALYSIS CONSISTING OF SCANNING ELECTRON MICROSCOPE (SEM) REVEALED THAT THE TWO BALLOON APPLICATORS FROM LOT # 01811131 FAILED DUE TO AN EXTERNAL OBJECT PROTRUDING THE SURFACE OF THE BALLOON (I.E., SYRINGE, SCALPEL, ETC.). THE THIRD BALLOON APPLICATOR FROM LOT # 01810162 COULD NOT BE CONFIRMED FOR ITS FAILURE CAUSE. THE FAILURE ANALYSIS CONCLUDES THAT USER ERROR CONTRIBUTED TO THE FAILURE OF THE TWO DEVICES FROM LOT # 01811131 AND THAT NO ROOT CAUSE IS CONFIRMED FOR THE SINGLE DEVICE FROM LOT # 01810162.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE ANALYSIS IS STILL UNDER INVESTIGATION. FINAL REPORT IS PENDING. DEVICE LOT NUMBERS, MANUFACTURING, AND EXPIRATION DATES ARE GIVEN BELOW: LOT # 01810162 (2 DEVICES), MANUFACTURE DATE: NOVEMBER 2018, EXPIRATION DATE: NOVEMBER 2021. LOT # 01811131 (1 DEVICE), MANUFACTURE DATE: DECEMBER 2018, EXPIRATION DATE: DECEMBER 2021.

    Description of Event or Problem · 1

    TREATING CLINICAL SITE LOCATED IN (B)(6), REPORTED THE FAILURE OF THREE 3-4 CM BALLOON CATHETERS BEING USED TO TREAT PATIENTS UNDERGOING INTRA-OPERATIVE RADIATION THERAPY (IORT) FOR BREAST CANCER. THE TREATING FACILITY REPORTED THAT TWO SUCH DEVICES RUPTURED IN THE PATIENT WHILE THE PHYSICIAN ATTEMPTED TO INJECT STERILE WATER INTO THE DEVICE. THE THIRD DEVICE WAS BEING PREPARED TO BE USED IN A SECOND PATIENT BUT HAD RUPTURED WHILE ATTEMPTING TO PRE-INFLATE THE DEVICE BEFORE BEING USED IN THE PATIENT. ALL THREE DEVICES WERE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. BOTH PATIENTS SUSTAINED NO INJURY AND BOTH PATIENT PROCEDURES WERE COMPLETED WITH BACKUP 3-4 CM BALLOON CATHETERS FROM THE MANUFACTURER. INTERNAL COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76748 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 3-4 CM, SPERICAL JAD XOFT, A SUBSIDIARY OF ICAD, INC. 720340 SEE NARRATIVE, SECTION H-10

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other