BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1022595 · Received April 1, 2008

    Report

    Report Number
    1219856-2008-00164
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SEE MEDWATCH 1219856-2008-00163 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT THE SECOND INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND INSERTED SHEATHLESS VIA THE FEMORAL ARTERY. THE MD NOTICED BLOOD IN THE HELIUM DRIVE LINE AS SOON AS THE IAB WAS IN PLACE. AS A RESULT, THE DRIVE LINE TUBING WAS DISCONNECTED FROM THE PUMP AND THE IAB WAS REMOVED. THE MD REQUESTED ANOTHER BRAND IAB AND PUMP. THE MD WAS ABLE TO INSERT THE THIRD IAB WITH SUCCESS. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention