BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL

    MDR report key: 2823620 · Received July 17, 2008

    Report

    Report Number
    2182269-2008-00387
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS IN THE PROCESS OF EVALUATING THIS DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE AGILIS WAS INSERTED IN THE BODY, AND MANEUVERED THROUGH THE SEPTUM INTO THE LEFT ATRIUM. WHEN THE DILATOR WAS REMOVED, ARTERIAL BLOOD STARTED LEAKING FROM THE CONNECTION BETWEEN THE SIDEPORT AND THE AGILIS BODY. WHEN THE AGILIS WAS REMOVED FROM THE BODY, IT WAS NOTED THAT THE SIDEPORT WAS SHEARED WITHIN THE BODY OF THE AGILIS. ANOTHER AGILIS FROM THE SAME LOT WAS OPENED AND USED. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL AGILIS NXT, 8.5F DYB ST. JUDE MEDICAL NA 2027008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK