BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1621262 · Received February 12, 2010

    Report

    Report Number
    1219856-2010-00083
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 12, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). F/U REPORT WILL BE FILED IF ADD'L 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 AND THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED INTO THE PT'S FEMORAL ARTERY. THE IAB WAS UNABLE TO BE ADVANCED THROUGH THE SAF SHEATH. AS A RESULT, THE IAB AND THE SAF SHEATH WERE REMOVED AS ONE UNIT. THE MD INSERTED A SECOND SAF SHEATH INTO THE SAME INSERTION SITE AS THE FIRST SAF SHEATH AND IAB. THERE WAS NO EXCESSIVE BLEEDING. THE SECOND IAB WAS PREPPED AND INSERTED THROUGH THE SAF SHEATH WITHOUT DIFFICULTIES. 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR