BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW/KONTRON 9FR INTRA-AORTIC BALLOON

    MDR report key: 160242 · Received March 30, 1998

    Report

    Report Number
    1219856-1998-00061
    Event Type
    Injury
    Date Received
    March 30, 1998
    Date of Event
    March 20, 1998
    Report Date
    March 26, 1998
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON ON THE IAB RUPTURED DURING USE. THE IAB WAS REMOVED AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW/KONTRON 9FR INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention