BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30CC

    MDR report key: 2193270 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00252
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CATH LAB THAT WHILE INSERTING AN INTRA-AORTIC BALLOON (IAB) IN THE RIGHT FEMORAL ARTERY, IT COULD NOT BE ADVANCED INTO THE VESSEL. THE IAB AND TEFLON SHEATH WERE REMOVED AS ONE UNIT AND ANOTHER IAB WAS INSERTED WITHOUT ISSUES. IT IS NOTED THE IAB WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE SECOND INSERTION SITE WAS THE SAME AS THE FIRST. THE PT VESSEL WAS LIGHTLY CALCIFIED AND MAY POSSIBLY HAVE BEEN TORTUOUS. THERE WERE NO COMPLICATIONS OR DELAY IN THERAPY AND THE PT'S OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 30CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9067248

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR