BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 40 CC FOS

    MDR report key: 1963645 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00910
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 17, 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
    GM
    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 THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH AND INTO THE PATIENT'S RIGHT FEMORALIS. THE RN TOLD THE SALES REP THAT THE IAB WAS DEFECTIVE. AT THIS TIME, THERE IS NO MORE INFO ABOUT THE DETAILS OF THE EVENT. THERE WAS NO PT DEATH OR INJURY. A NEW IAB WAS INSERTED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK