BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3840331 · Received March 30, 2014

    Report

    Report Number
    3840331
    Event Type
    Injury
    Date Received
    March 30, 2014
    Date of Event
    January 14, 2014
    Report Date
    March 30, 2014
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMORAL ARTERY WAS TORN WHILE TRYING TO ACCESS IT WITH AN ARSTASIS AXERA 2 ACCESS SYSTEM. THE PATIENT WENT TO THE OR FOR REPAIR. CORONARY ANGIOGRAPHY WAS CONTINUED WHILE PRESSURE WAS APPLIED TO THE FEMORAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187158 AXERA 2 ACCESS SYSTEM INTRODUCER, CATHETER DYB ARSTASIS, INC. * 13I06088

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R OTHER| NOT SPECIFIED| ILIAC ARTERY BALLOON AND LIKELY OTHERS, ALTHOUGH