BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI

    MDR report key: 3835670 · Received May 21, 2014

    Report

    Report Number
    MW5036260
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CIANNA MEDICAL
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A SAVI BREAST CATHETER USED FOR ACCELERATED PARTIAL BREAST IRRADIATION HAD 2 STRUTS (#2 AND 9) THAT FAILED TO DEPLOY IN THE PT'S BREAST. AS A RESULT OF THE MALFUNCTION THE CATHETER WAS REMOVED AND TREATMENT FOR BREAST CANCER WAS DELAYED. THIS IS THE THIRD SAVI APBI BREAST CATHETER IN THE LAST 90 DAYS THAT HAS FAILED TO PERFORM AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303028 SAVI BREAST CATHETER JAQ CIANNA MEDICAL 8-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other