BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS¿ INTRODUCER, UNKNOWN

    MDR report key: 4083941 · Received September 12, 2014

    Report

    Report Number
    3005188751-2014-00108
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ONE AGILIS NXT INTRODUCER WAS RETURNED FOR EVALUATION. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT NO LEAKS WERE OBSERVED DURING FUNCTIONAL TESTING OF THE SHEATH. IN ADDITION, NO VISUAL ANOMALIES WERE NOTED ON THE SHEATH. THE DEVICE HISTORY RECORD FOR THE ABOVE-REFERENCED PRODUCT WAS UNABLE TO BE REVIEWED SINCE THE BATCH NUMBER IS UNKNOWN. THE CAUSE OF THE REPORTED AIR EMBOLISM REMAINS UNKNOWN. PER THE IFU, AIR EMBOLISM IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THERE WAS LEAKAGE FROM THE HEMOSTASIS VALVE OF THE AGILIS NXT INTRODUCER WHEN THE ABLATION CATHETER WAS REMOVED. THERE WAS NO LEAKAGE FROM THE VALVE WHILE THE ABLATION CATHETER WAS INSIDE THE INTRODUCER.

    Description of Event or Problem · 1

    AT THE CONCLUSION OF AN ATRIAL TACHYCARDIA ABLATION PROCEDURE USING AN AGILIS NXT INTRODUCER, AN AIR EMBOLISM OCCURRED. THE ABLATION CATHETER WAS REMOVED FROM THE AGILIS NXT INTRODUCER. THE PATIENT THEN DEVELOPED ST ELEVATION AND AN AIR EMBOLISM WAS NOTED WITHIN THE HEART VIA FLUOROSCOPY. THE ST ELEVATION RESOLVED SPONTANEOUSLY AND NO INTERVENTION WAS REQUIRED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564947 AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention