BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 4022968 · Received May 14, 2014

    Report

    Report Number
    4022968
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR AN ABDOMINAL AORTOGRAM AND RIGHT LOWER EXTREMITY RUNOFF, RIGHT SUPERFICIAL FEMORAL ARTERY RECANNULIZATION, ANGIOPLASTY, AND STENT SECONDARY TO NONHEALING ULCER IN INFERIOR RECTUS. AT THE END OF THE PROCEDURE ATTEMPT WAS MADE TO OBTAIN HEMOSTASIS WITH A PROGLIDE CLOSURE DEVICE. THE DEVICE FAILED AND ADHERED TO THE VESSEL AND NEEDED TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289021 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC * 31023K1

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR