BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUETT PRO

    MDR report key: 621616 · Received July 18, 2005

    Report

    Report Number
    2134812-2005-00454
    Event Type
    Injury
    Date Received
    July 18, 2005
    Date of Event
    June 21, 2005
    Report Date
    July 18, 2005
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DUETT PRO WAS DEPLOYED FOLLOWING A DIAGNOSTIC PROCEDURE VIA THE RIGHT COMMON FEMORAL ARTERY. TWENTY MINUTES AFTER DEPLOYMENT, THE PATIENT DEVELOPED LOSS OF PULSE AND PAIN. AN ANGIOGRAM CONFIRMED A LOCALIZED ARTERIAL OCCLUSION. THE PATIENT WAS TREATED WITH THROMBOLYTIC THERAPY, ANTICOAGULATION THERAPY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND PERCUTANEOUS THROMBECTOMY. THE EVENT WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. SEVERE PERIPHERAL VASCULAR DISEASE (PVD) WAS NOTED. THE INSTRUCTIONS FOR USE CONTAIN A WARNING AGAINST USE IN THE PRESENCE OF PVD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUETT PRO VASCULAR SEALING DEVICE MGB VASCULAR SOLUTIONS, INC. 1010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention