BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT REFLECTOR & DELIVERY SYSTEM

    MDR report key: 10065054 · Received May 15, 2020

    Report

    Report Number
    MW5094526
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 14, 2020
    Manufacturer
    CIANNA MEDICAL INC. / MERIT MEDICAL SYSTEMS, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING BREAST SAVI SCOUT PLACEMENT WHEN THE REFLECTOR DID NOT DEPLOY PROPERLY FROM THE SAVI SCOUT DEVICE. THE REFLECTOR WAS STUCK IN THE END OF THE NEEDLE. SECOND DEVICE OBTAINED AND REFLECTOR DEPLOYED WITHOUT INCIDENT FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524784 SAVI SCOUT REFLECTOR & DELIVERY SYSTEM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL INC. / MERIT MEDICAL SYSTEMS, INC. ML04900

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR