BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW 8 FR 40CC INTRA-AORTIC BALLOON

    MDR report key: 506188 · Received January 12, 2004

    Report

    Report Number
    1219856-2004-00005
    Event Type
    Death
    Date Received
    January 12, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 6, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IAB WAS INSERTED FOLLOWING OPEN HEART SURGERY. THREE DAYS AFTER INSERTION, THE PUMP CONSOLE FILLED WITH BLOOD INDICATING A BALLOON RUPTURE. AFTER THE BALLOON RUPTURE, THE PT'S CONDITION DECLINED RAPIDLY. THE IAB WAS REPLACED 1 1/2 HOURS AFTER THE SUSPECTED BALLOON RUPTURE. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW 8 FR 40CC INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP ARROW INTERNATIONAL, INC. NA MF3095697

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death EPINEPHRINE, LEVOPHED, PRIMACOR.