BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW/KONTRON 8FR INTRA-AORTIC BALLOON

    MDR report key: 183509 · Received August 21, 1998

    Report

    Report Number
    1219856-1998-00158
    Event Type
    Injury
    Date Received
    August 21, 1998
    Date of Event
    July 1, 1998
    Report Date
    August 20, 1998
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA AORTIC BALLOON WAS INSERTED INTO A PT WITH CARDIOGENIC SHOCK. BLOOD WAS NOTED IN THE TUBING AND THE INTRA AORTIC BALLOON WAS REMOVED AND REPLACED. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW/KONTRON 8FR INTRA-AORTIC BALLOON Implant INTRA-AORTIC BALLOON DSP ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention