BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICE

    MDR report key: 15879092 · Received November 28, 2022

    Report

    Report Number
    MW5113511
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 22, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FIVE PROGLIDE/PERCLOSE DEVICES WERE USED AT THE BEGINNING OF THE SURGERY. THE FIRST ONE MISFIRED. UPON COMPLETION OF THE SURGERY, TWO OF THE OTHER FOUR MALFUNCTIONED. THIS RESULTED IN SIGNIFICANT BLOOD LOSS AND REPAIR OF THE FEMORAL ARTERIES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330296 ABBOTT VASCULAR PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR
    2330297 ABBOTT VASCULAR PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR
    2330298 ABBOTT VASCULAR PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12673-03 2100741

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening| R