BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1220648-2018-00046

    MDR report key: 7488364 · Received May 4, 2018

    Report

    Report Number
    1220648-2018-00046
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 6, 2018
    PMA / PMN Number
    P1400003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT AND DATA LOGS WERE RETURNED AND EVALUATED. THE RETURNED DATA LOGS INDICATE THE PUMP MAY NOT HAVE BEEN IN PROPER POSITION THROUGHOUT SUPPORT. THERE WERE NO MAJOR ABNORMALITIES NOTED ON THE RETURNED PUMP. THERE WERE SOME SCRATCHES ON THE PUMP HOUSING WINDOW, INDICATING POSSIBLE WITNESS MARKS FROM INTERACTION WITH THE GUIDEWIRE, HOWEVER THE ROOT CAUSE OF THE GUIDEWIRE FRACTURE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ABIOMED HAS RECEIVED THE DEVICE. THE PRODUCT HAS NOT YET BEEN EVALUATED. A SUPPLEMENTAL REPORT WILL BE SENT AFTER DEVICE EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE IMPELLA WAS POSITIONED IN THE LEFT VENTRICLE. THE 0.018 GUIDE WIRE WAS REMOVED WITH SLIGHT RESISTANCE. THE PUMP WAS EXPLANTED AND A PIECE OF THE GUIDE WIRE WAS FOUND IN THE CANNULA.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention