BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUETT PRO SEALING DEVICE

    MDR report key: 467126 · Received June 20, 2003

    Report

    Report Number
    2134812-2003-00389
    Event Type
    Death
    Date Received
    June 20, 2003
    Report Date
    June 19, 2003
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DUETT PRO SEALING DEVICE WAS DEPLOYED FOLLOWING A DIAGNOSTIC PROCEDURE VIA A 7 FR SHEATH IN THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT HAD AN EXISTING SPINAL TUMOR. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS (DVT) UNRELATED TO THE DUETT PRO, WHICH WAS TREATED WITH HEPARIN AND SUBSEQUENTLY DEVELOPED UNDEFINED BLEEDING COMPLICATIONS. HEPARIN WAS DISCONTINUED. THREE DAYS FOLLOWING THE PROCEDURE THE PATIENT WAS RELEASED FROM THE HOSTIPAL TO AN OUTSIDE REHABILITATION FACILITY WITH NORMAL LAB RESULTS. NINE DAYS INTO THE PATIENT'S STAY AT THE REHABILITATION CENTER THEY EXPERIENCED A DROP IN HEMOGLOBIN FOLLOWING BLEEDING EVENT FROM THE PUNCTURE SITE. THE PATIENT SUBSEQUENTLY EXPIRED. VASCULAR SOLUTIONS HAS BEEN UNABLE TO CLARIFY THE NATURE OF THIS BLEEDING EVENT OR OBTAIN FURTHER INFORMATION FROM THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death