BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 4884090 · Received June 16, 2015

    Report

    Report Number
    MW5043413
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ABBOTT
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL GROIN DISSECTION WITH AORTA BIFURCATION - BALLOON TIP WOULD NOT LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390194 ABBOTT VASCULAR ARMADA 35 PTA CATHETER LIT ABBOTT 50213G1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR