BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSEAL

    MDR report key: 2792460 · Received October 10, 2012

    Report

    Report Number
    MW5027238
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANGIOSEAL, VASCULAR CLOSURE DEVICE, DID NOT DEPLOY PROPERLY AFTER PROCEDURE WAS COMPLETED. MANUAL PRESSURE WAS APPLIED TO THE RFA UNTIL HEMOSTASIS WAS ACHIEVED. NO HEMATOMA WAS DEMONSTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR CLOSURE DEVICE MGB ST JUDE MEDICAL 3731307

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention