BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR SOLUTIONS DUETT SEALING DEVICE

    MDR report key: 350062 · Received September 6, 2001

    Report

    Report Number
    2134812-2001-00162
    Event Type
    Injury
    Date Received
    September 6, 2001
    Date of Event
    August 10, 2001
    Report Date
    September 6, 2001
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D ABOUT THIS EVENT SHOWED THAT TWO DAYS FOLLOWING THE SURGICAL THROMBECTOMY, AN ABOVE THE KNEE AMPUTATION WAS PERFORMED. THE PT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    THE DUETT SEALING DEVICE WAS DEPLOYED FOLLOWING A DIAGNOSTIC PROCEDURE, VIA A 7 FR SHEATH IN THE RIGHT COMMON FEMORAL ARTERY. THE PT EXPERIENCED LEG PAIN AND ABSENT PEDAL PULSES. AN ANGIOGRAM WAS TAKEN OF THE RIGHT LEG. A VASCULAR SURGEON WAS CONSULTED AND THE PT UNDERWENT A SURGICAL THROMBECTOMY. DURING THE SURGICAL INTERVENTION THE SURGEON FOUND DISSECTION OF THE RIGHT ILIAC ARTERY AND COMMON FEMORAL ARTERY. THE ANGIOGRAM SHOWED CHRONIC OCCLUSION IN THE ARTERY, AND THE LOWER LEG AND SUPERFICIAL FEMORAL ARTERY WERE FED BY COLLATERAL CIRCULATION. THE EVENT WAS RESOLVED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40260 VASCULAR SOLUTIONS DUETT SEALING DEVICE VASCULAR HEMOSTASIS DEVICE MGB VASCULAR SOLUTIONS, INC. 1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention