BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1063686 · Received June 20, 2008

    Report

    Report Number
    1219856-2008-00296
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD SLIDE THE FIBER OPTIX SENSOR (FOS) SLIDE KEY INTO THE PUMP, AND THE PUMP WOULD NOT ZERO. THEY "TRIED WITH ANOTHER PUMP, AND WAS ABLE TO ZERO, BUT THE BALLOON WOULD NOT RECALL PREVIOUS ZERO." THE MD DECIDED TO USE THE IAB WITH THE TRANSDUCER. THE MD WAS UNABLE TO PASS THE IAB OVER THE GUIDEWIRE AND THROUGH THE SHEATH. AS A RESULT, A NEW IAB WAS USED WITHOUT DIFFICULTY.

    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 INTL., INC. MF8029111

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention