BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 7074895 · Received November 30, 2017

    Report

    Report Number
    MW5073672
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO CLOSE FEMORAL ARTERY USING THE ABBOTT PERCLOSE DEVICE APPROX 20 CM OF THE TIP FRACTURED OFF INTO THE ARTERY. THIS REQUIRED SURGICAL INTERVENTION FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852429 ABBOTT PERCLOSE PROGLIDE MGB ABBOTT VASCULAR 7101141

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization