BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL 6 FR

    MDR report key: 1772077 · Received July 20, 2010

    Report

    Report Number
    1772077
    Event Type
    Malfunction
    Date Received
    July 20, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DUE TO ANTICOAGULATION, PHYSICIAN CAME INTO PROCEDURE TO SEAL THE GROIN. AN ANGIOSEAL WAS DEPLOYED & THE PATIENT SUBSEQUENTLY HAD LOSS OF PULSES ON THE RIGHT FOOT & THE EXTREMITY BECAME COOL AND MOTTLED. RIGHT FEMORAL ARTERY WAS OCCLUDED WITH BLOOD CLOTS. FLOW SUCCESSFULLY RESTORED VIA BALLOONING WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 3 FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL 6 FR DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL * 3064634

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR