BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 6431630 · Received March 22, 2017

    Report

    Report Number
    MW5068644
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 20, 2017
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT CORONARY ANGIOGRAM. ANGIOSEAL WAS DEPLOYED, HOWEVER THE ANCHOR DID NOT MAINTAIN RESULTING IN ANGIOSEAL FAILURE REQUIRING MANUAL COMPRESSION OF GROIN. LOT # 5800729. NO GROIN ISSUES AFTER MANUAL COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208784 ST JUDE MEDICAL ANGIOSEAL 6F MGB ST JUDE MEDICAL 5800729

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention