BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCU-GUARD

    MDR report key: 6033771 · Received October 17, 2016

    Report

    Report Number
    6033771
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 11, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6), A PATIENT HAD A LEFT CAROTID ENDARTERECTOMY WITH BOVINE PATCH ANGIOPLASTY AND TEMPORARY SHUNT PLACEMENT USING VASCU-GUARD VG-0108N, LOT # SP16D12-1140707, EXPIRATION DATE 1/18/2021, DILUENT NS, PACKAGE INTACT. THE SAME DATE, THE VASCULAR SURGEON WAS REPORTEDLY NOTIFIED OF THE BAXTER SAFETY ALERT DATED FOUR DAYS PREVIOUSLY WHEREIN THIS LOT NUMBER IS LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685847 VASCU-GUARD PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ BAXTER HEALTHCARE CORPORATION SP16D12-1140707

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR RUNNING 5-0 PROLENE SUTURE.PRUITT-INAHARA SHUNT