BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 1031469 · Received April 18, 2008

    Report

    Report Number
    1219856-2008-00196
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    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 THE CLINICIAN ASPIRATED AIR FROM THE BALLOON WITH THE 60CC SYRINGE. THEY THEN TRIED TO INSERT THE BALLOON INTO THE SHEATH, BUT THE BALLOON MEMBRANE UNWRAPPED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF6057930

    Patients

    Seq Age Sex Outcome Treatment
    1