BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1900553 · Received October 29, 2010

    Report

    Report Number
    1219856-2010-00761
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIAC CATH LAB (CCL), THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND CALIBRATED IN THE "NORMAL FASHION." UPON INSERTING THE IAB THROUGH THE 8FR SHEATH, THE MD MET WITH "A LOT OF RESISTANCE." THE CCL MANAGER REPORTED THAT THE IAB UNRAVELED AND AS A RESULT, ANOTHER IAB WAS OPENED, PREPPED AND USED WITHOUT DIFFICULTIES. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB THERAPY WAS INTERRUPTED / DELAYED; HOWEVER, THE TIME FRAME IS UNK. THERE WERE NO REPORTED PT 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 INTL., INC. MF0032013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK