BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1172867 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00447
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 PHYSICIAN, THE CATHETER WAS TWISTED, AND THE INTRA-AORTIC BALLOON (IAB) WOULD NOT INFLATE CORRECTLY. THEY ALSO STATED DUE TO THE DANGEROUS DISEASE, THE PATIENT EXPIRED. THEY DO NOT FEEL IT WAS DUE TO THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF7065955

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death