BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT LOWE PKG ASSY

    MDR report key: 2854494 · Received November 29, 2012

    Report

    Report Number
    3005188751-2012-00316
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AIR LEAK OCCURRED FROM THE HEMOSTASIS VALVE OF AN AGILIS INTRODUCER DURING AN ABLATION PROCEDURE. AFTER THE PATIENT WAS ACCESSED, A GUIDEWIRE WAS INSERTED INTO THE PATIENT. THE DILATOR/INTRODUCER ASSEMBLY WAS INSERTED OVER THE GUIDEWIRE. THE PHYSICIAN FLUSHED THE AGILIS INTRODUCER SIDE PORT AND NOTED AIR BUBBLES FROM THE HEMOSTASIS VALVE. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT LOWE PKG ASSY CATHETER, INTRODUCER DYB ST. JUDE MEDICAL, INC (AF-MINNETONKA) G408318 3783641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BRK TRANSSEPTAL NEEDLE, MODEL 407208