BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSEAL DEVICE

    MDR report key: 1013913 · Received March 14, 2008

    Report

    Report Number
    MW5005874
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ST JUDE MEDICAL, CARDIOLOGY DIVISION
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PAST DEPLOYMENT OF ANGIOSEAL (COLLAGEN PLUG), THE DILATOR AND THE INTRODUCER COULD NOT BE REMOVED BY THE PHYSICIAN. PT WAS REFERRED TO A VASCULAR SURGEON AND WAS SENT TO OR FOR EMBOLECTOMY AND REMOVAL OF FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL DEVICE ANGIOSEAL MGB ST JUDE MEDICAL, CARDIOLOGY DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention