BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 660078 · Received December 16, 2005

    Report

    Report Number
    660078
    Event Type
    Injury
    Date Received
    December 16, 2005
    Date of Event
    October 26, 2005
    Report Date
    December 16, 2005
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A LEFT INTERNAL CAROTID ARTERY DILATATION AND STENTING. A PERCLOSE DEVICE WAS PLACED AND AN ATTEMPT AT CLOSURE WAS MADE WITH THIS DEVICE, BUT THE DEVICE FAILED. THE STITCH BROKE. THEREFORE, THE GUIDEWIRE AND THE PERCLOSE WERE REMOVED AND PRESSURE WAS APPLIED TO THE GROIN AS THE PATIENT WAS GIVEN 75 MG OF PROTAMINE INTRAVENOUSLY. A C CLAMP DEVICE WAS THEN APPLIED FOR 20-MINUTES AFTER 10-MINUTES OF MANUAL PRESSURE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO NEUROLOGICAL OR MEDICAL ISSUES DURING THE OPERATIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR PERCLOSE PROGLIDE MGB ABBOTT VASCULAR DEVICES REF 12673 28101-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention