BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 15752281 · Received November 8, 2022

    Report

    Report Number
    3008452825-2022-00671
    Event Type
    Injury
    Date Received
    November 8, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSIONS AND VASCULAR ACCESS COMPLICATION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3005334138-2022-00605, 3005334138-2022-00606, 2182269-2022-00056. THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR DEVELOPMENT AND DISEASE TITLED: "INCIDENCE OF LONG-TERM PULMONARY VEIN RECONNECTION AFTER A 2-MINUTE CRYOBALLOON FREEZE FOR PULMONARY VEIN ISOLATION¿INVASIVE INSIGHTS OF TTI-DEPENDENT CRYOENERGY TITRATION", J. CARDIOVASC. DEV. DIS. 2022, 9, 284. HTTPS://DOI.ORG/10.3390/JCDD9090284, ALEXANDER POTT, MD. CONSECUTIVE PATIENTS WITH AF RECURRENCE WHO UNDERWENT A SECOND AF ABLATION PROCEDURE AFTER INITIAL CRYOBALLOON PVI AT ULM UNIVERSITY MEDICAL CENTER WERE INCLUDED. INITIAL CRYOABLATION WAS PERFORMED EITHER BY A FIXED PROTOCOL OR A TTI-GUIDED PROTOCOL (FIGURE 1). WRITTEN INFORMED CONSENT WAS OBTAINED FROM EACH PATIENT PRIOR TO THE PROCEDURE AND THE PROTOCOL WAS APPROVED BY OUR LOCAL ETHICS COMMITTEE. THE INVESTIGATION CONFORMED WITH THE PRINCIPLES OUTLINED IN THE DECLARATION OF HELSINKI. THE EXCLUSION CRITERIA WERE LA DIAMETER OF >60 MM, UNCONTROLLED HEART FAILURE (NYHA CLASS IV) AND SEVERE VALVULAR DISEASE. FOUR PERICARDIAL EFFUSIONS AND ONE VASCULAR ACCESS COMPLICATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178869 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other