BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1230359 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00501
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MEDWATCH 1219856-2008-00499 FOR THE FIRST EVENT AND MEDWATCH 1219856-2008-00500 FOR THE SECOND EVENT INVOLVING THE SAME PT. THE THIRD INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND THE SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE IAB WAS INSERTED AND WITHIN "SECONDS" THE PUMP, KAATII PLUS ALARMED "HIGH PRESSURE". UNDER FLUOROSCOPY, THE MD SAID THE IAB SEEMED TO NOT BE FULLY INFLATED DISTALLY. AS A RESULT, THE IAB WAS REMOVED AND A FOURTH IAB WAS INSERTED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF8050988

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR