BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 2214047 · Received August 9, 2011

    Report

    Report Number
    2214047
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ABIOMED
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    I WAS INFORMED THAT IMPELLA WAS DEFECTIVE AND LEAKING AT THE CONNECTION AND REMOVED FROM THE PT. THE PT WAS BROUGHT TO THE CATH LAB FOR AN IMPELLA INSERTION. WHEN THE ORIGINAL IMPELLA CATHETER WAS INSERTED, THE CONNECTION WAS LEAKING AND THEY COULD NOT GET THE PRESSURE TO RISE. THE REP FROM ABIOMED DETERMINED THE CATHETER WAS DEFECTIVE. THE CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED WITHOUT INCIDENT. THE REP TOOK THE CATHETER WITH HIM TO BE EVALUATED BY THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPELLA IMPELLA KFM ABIOMED 2.5 2012112043

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR