BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR ARMADA

    MDR report key: 5327363 · Received December 22, 2015

    Report

    Report Number
    MW5058732
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 21, 2015
    Report Date
    December 21, 2015
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    ARMADA BALLOON LEAKED. INJECTION PORT CONNECTER SITE, TO THE BALLOON SITE. REMOVED BALLOON. OPENED UP NEW BALLOON. AND PERFORMED ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846581 ABBOTT VASCULAR ARMADA 50MM X 80MM, X 135CM LIT 40814G1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR