BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC

    MDR report key: 1172864 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00436
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 30, 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
    BR
    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 THAT THE PATIENT SUFFERED FROM CARDIOGENIC SHOCK. THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND MD DID NOT USE A SHEATH. WHILE THREADING THE IAB OVER THE GUIDEWIRE, THE GUIDEWIRE BECAME STUCK AT THE BIFURCATION. AS A RESULT, THE MD USED ANOTHER IAB AND THE INSERTION WAS SUCCESSFUL. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF6079580

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR