BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1203526 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00488
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OPERATING THEATER THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE SHEATH WAS INSERTED VIA THE RIGHT FEMORAL ARTERY. THE IAB WAS INSERTED PART-WAY INTO THE SHEATH WHEN IT BECAME STUCK. THE MD WAS ABLE TO REMOVE THE IAB WITHOUT THE SHEATH. THE MD MADE A REQUEST FOR ANOTHER IAB. REFERENCE MEDWATCH 1219856-2008-00489 FOR A SECOND EVENT INVOLVING SAME PATIENT.

    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 INTERNATIONAL INC. MF8050995

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR