BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR-40 CC FOS

    MDR report key: 1172869 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00438
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTL., 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

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A MALE PATIENT IN THE OPERATING THEATER. AFTER THE BALLOON WAS PREPPED, THEY ATTEMPTED TO INSERT THE BALLOON INTO THE SHEATH. THE BALLOON UNWRAPPED AND WAS NOT ABLE TO BE ADVANCED INTO THE SHEATH. AS A RESULT, ANOTHER CATHETER WAS OPENED AND USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR-40 CC FOS INTRA- AORTIC BALLOON FIBER OPTIC SYTSEM (FOS) DSP ARROW INTL., INC. MF8050721

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR