BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1210383 · Received October 13, 2008

    Report

    Report Number
    1210383
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ANGIOGRAM: ILIAC/PTA/STENT. THE PATIENT'S LEFT COMMON FEMORAL ARTERY WAS ACCESSED FOR AN AP AORTOGRAM AND ANGIOGRAM AND A STARCLOSE DEVICE WAS USED FOR CLOSURE. THERE WAS SOME TYPE OF MISFIRING OF THE STARCLOSE DEVICE WHICH DID NOT ALLOW TO RELEASE. THE PHYSICIAN THEN MADE AN INCISION IN THE LEFT GROIN TO MANUALLY REMOVE THE STARCLOSE DEVICE AND THEN HELD PRESSURE MANUALLY OVER THE FEMORAL ARTERY FOR 15 MINUTES. SOME SURGICEL WAS PLACED AND THE INCISION WAS SEWN SHUT. THE PATIENT TOLERATED THE PROCEDURES WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR DEVICES * 670046H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR