BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW 7.5 FR 40 CC INTRA-AORTIC BALLOON

    MDR report key: 507910 · Received January 23, 2004

    Report

    Report Number
    1219856-2004-00007
    Event Type
    Death
    Date Received
    January 23, 2004
    Report Date
    January 7, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IAB WAS INSERTED IN A PATIENT IN CRITICAL CONDITION WITH END STAGE LIVER DISEASE, AND COAGULOPATHY. THE IAB WAS INSERTED VIA THE LEFT FEMORAL ARTERY WITHOUT THE GUIDANCE OF X-RAY. AFTER THREE DAYS OF USE AND ATTEMPTS TO REPOSITION THE IAB SINCE IT WAS TOO LOW IN THE AORTA, KINKED CATHETER ALARMS WERE EXPERIENCED. THE IAB WAS LEFT IN PLACE UNTIL A FEW DAYS LATER WHEN THE PT EXPIRED. THE DECISION TO LEAVE THE IAB IN PLACE WAS BASED ON THE BELIEF THAT A "PHYSIOLOGICAL PROCESS" WAS CAUSING THE DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW 7.5 FR 40 CC INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death