BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR-40 CC FOS

    MDR report key: 1172870 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00437
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION PROCESS, THE INTRA-AORTIC BALLOON (IAB) BECAME STUCK IN THE SHEATH (SUPER ARROW-FLEX STYLE WITH SIDE ARM) AND WOULD NOT ADVANCE, NOR COULD IT BE REMOVED FROM THE SHEATH. THE BALLOON TIP HAD JUST BEGUN TO EXIT THE END OF THE SHEATH WHEN IT BECAME TOTALLY JAMMED. THE ENTIRE IAB WITH SHEATH ASSEMBLY WAS REMOVED SUCCESSFULLY. FOLLOW UP FROM THE SALES REPRESENTATIVE STATED A DATASCOPE BALLOON WAS THEN USED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DATASCOPE| INTRA-AORTIC BALLOON