BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, IMPELLA 2.5

    MDR report key: 2201262 · Received July 22, 2011

    Report

    Report Number
    2201262
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ABIOMED, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IMPELLA GUIDE WIRE WAS ADVANCED INTO THE LEFT VENTRICLE AND THE CATHETER SYSTEM WAS ADVANCED OVER THE WIRE INTO THE VENTRICLE AND POSITIONED. THE IMPELLA LEFT VENTRICULAR ASSISTIVE DEVICE WAS RAMPED UP TO P4, BUT FLOWS WERE REGISTERING IN THE 0.2 RANGE. AFTER TROUBLE SHOOTING WHICH INCLUDED REPOSITIONING OF THE CATHETER THE DECISION WAS MADE THEN TO COMPLETELY REMOVE THE IMPELLA DEVICE. AFTER THE DEVICE WAS REMOVED, IT WAS TESTED OUTSIDE THE BODY, WHERE IT WAS SUBMERGED IN WATER AND AGAIN RAMPED TO P4, BUT THE CATHETER REGISTERED 0.2 FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, IMPELLA 2.5 MEDICAL DEVICE (IABP) KFM ABIOMED, INC. * 004672

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR