BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 6935619 · Received October 10, 2017

    Report

    Report Number
    6935619
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 6, 2017
    Manufacturer
    ABIOMED
    Product Code
    OJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REQUIRED PLACEMENT OF AN IMPELLA VENTRICULAR ASSIST DEVICE VIA LEFT COMMON FEMORAL INTRODUCER SHEATH. THE DEVICE BECAME ENTRAPPED ON ATTEMPT AT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714670 IMPELLA IMPELLA LEFT VENTRICULAR ASSIST DEVICE OJE ABIOMED 129265

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other