BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCULAR SOLUTIONS DUETT SEALING DEVICE

    MDR report key: 375224 · Received February 6, 2002

    Report

    Report Number
    2134812-2002-00243
    Event Type
    Death
    Date Received
    February 6, 2002
    Date of Event
    December 13, 2001
    Report Date
    February 6, 2002
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DUETT SEALING WAS DEPLOYED FOLLOWING A DIAGNOSTIC PROCEDURE VIA A 5 F SHEATH IN THE LEFT COMMON FEMORAL ARTERY. FOLLOWING THE DEPLOYMENT, THE PATIENT EXPERIENCED A VASOVAGAL RESPONSE, REQUIRING ELEVATION ON THE LEGS. ADVANCED CARDIAC LIFE SUPPORT WAS STARTED. AFTER THE PATIENT STABILIZED, ABSENT PULSES WERE NOTED IN THE LEFT LEG. TREATMENT CONSISTED OF A THROMBOLECTOMY, RETAVASE INFUSION, AND THREE UNITS OF PACKED RED BLOOD CELLS. ON THE NEXT DAY, ONLY MINIMAL IMPROVEMENT WAS NOTED VIA ANGIOGRAM. FLOW WAS RESTORED VIA BYPASS. THE PATIENT EXPIRED IN THE WEEK FOLLOWING THE PROCEDURE FROM MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    THE INITIAL REPORT FILED ON THIS INCIDENT ATTRIBUTED THE PT'S DEATH TO THE DUETT DEVICE. THIS WAS IN ERROR AS THE PT'S DEATH WAS NOT RELATED TO THE REPORTED ADVERSE EVENT, BUT RATHER WAS ASSOCIATED WITH A SUBSEQUENT MYCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR SOLUTIONS DUETT SEALING DEVICE VASCULAR HEMOSTASIS DEVICE MGB VASCULAR SOLUTIONS, INC. 1000 300364

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R