BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGLIDE

    MDR report key: 1792009 · Received August 4, 2010

    Report

    Report Number
    1792009
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ENDOVASCULAR BILATERAL STENT BYPASS PROCEDURE AND WAS FOUND TO HAVE NO LEFT LOWER EXTREMITY PULSE IMMEDIATELY AFTER COMPLETION OF THE PROCEDURE. AN EXPLORATION OF THE PREVIOUS WOUND AND INTRAVASCULAR SITE WERE INITIATED AND A PIECE FROM THE PRECLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE WAS DISCOVERED IN THE INTRAVASCULAR SPACE BY THE SURGEON. THE SAME TYPE OF DEVICE FAILED BEFORE THIS ONE BY NOT SUTURING THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC REF 12673 870286H
    2 PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC REF 12673 870286H

    Patients

    Seq Age Sex Outcome Treatment
    1 *