BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUETT PRO SEALING DEVICE

    MDR report key: 478839 · Received August 20, 2003

    Report

    Report Number
    2134812-2003-00398
    Event Type
    Injury
    Date Received
    August 20, 2003
    Date of Event
    August 6, 2003
    Report Date
    August 20, 2003
    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

    THE DUETT PRO SEALING DEVICE WAS DEPLOYED FOLLOWING AN INTERVENTIONAL PROCEDURE VIA A 7 FR SHEATH. IT WAS REPORTED THAT THE PATIENT HAD A PUNCTURE SITE IN BOTH THE RIGHT AND LEFT GROIN TO ACCESS THE COMMON FEMORAL ARTERY. THE DUETT PRO WAS USED TO SEAL THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE. FOLLOWING THE DEPLOYMENT, THE PATIENT BECAME DIAPHORETIC WITH A DROP IN BLOOD PRESSURE AND DOPAMINE WAS ADMINISTERED. A RETROPERITONEAL BLEED WAS CONFIRMED HOWEVER, THE ORIGIN OF THE BLEED WAS NOT IDENTIFIED, AND THE PATIENT WAS INTUBATED. THE RIGHT AND LEFT GROIN PUNCTURE SITES WERE RE-ACCESSED TO AID IN TREATMENT. TREATMENT CONSISTED OF A BLOOD TRANSFUSION, PLATELET GP LLB/LLLA INHIBITOR (S) AND THE PLACEMENT OF A BALLOON PUMP IN THE RIGHT GROIN PUNCTURE SITE. THE TREATMENT WAS SUCCESSFUL AND THE EVENT WAS RESOLVED WITH NO FURTHER COMPLICATIONS.

    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 58 YR Required Intervention