BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT STARCLOSE SE

    MDR report key: 6587083 · Received May 22, 2017

    Report

    Report Number
    MW5069985
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 19, 2017
    Report Date
    May 22, 2017
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VASCULAR CLOSURE DEVICE MALFUNCTIONED. ATTENDING MD REMOVED RIGHT FEMORAL ARTERY SHEATH AND ABBOTT STARCLOSE SE LOT #7030241 FAILED TO DEPLOY AS INTENDED. MANUAL PRESSURE WAS HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362017 ABBOTT STARCLOSE SE STARCLOSE MGB ABBOTT VASCULAR 7030241

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other