BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW/KONTRON 8FR INTRA-AORTIC BALLOON

    MDR report key: 316881 · Received February 20, 2001

    Report

    Report Number
    1219856-2001-00040
    Event Type
    Injury
    Date Received
    February 20, 2001
    Report Date
    February 16, 2001
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE IAB, THE BALLOON UNWRAPPED BEFORE THE CATHETER WAS FULLY INSERTED. THE IAB WAS REMOVED AND REPLACED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6538 ARROW/KONTRON 8FR INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP ARROW INTL., INC. NA MF0100584

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention