BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 21335786 · Received February 7, 2025

    Report

    Report Number
    3008452825-2025-00053
    Event Type
    Injury
    Date Received
    February 7, 2025
    Report Date
    February 7, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEART AND VESSELS (2022) 37:1749¿1756. SPRINGER (2022) "COMPARISON OF OUTCOMES WITH LOW-POWER LONG DURATION VERSUS HIGH-POWER SHORT DURATION OF ABLATION: THE ROLE OF THE ACUTE CHANGE IN SINUS RHYTHM AFTER THE ABLATION AS A PREDICTOR OF LONG-TERM SUCCESS"; FABRICIO VASSALLO THE STUDY WERE CONDUCTED WITH 340 CONSECUTIVE PATIENTS WHO UNDERWENT A FIRST AF ABLATION AS PARTICIPANTS. ONLY PATIENTS IN SINUS RHYTHM AT THE BEGINNING AND THE END OF THE PROCEDURE WAS INCLUDED, WHO WERE IN THE DAY OF PROCEDURE IN AF WERE SUBMITTED TO ELECTRICAL CARDIOVERSION AN THOSE THAT NOT CONVERTED TO SINUS RHYTHM WERE EXCLUDED FROM THE ANALYSIS. THE DATA WERE COLLECTED BETWEEN JANUARY OF 2016 AND SEPTEMBER OF 2019. PATIENTS WERE DIVIDED INTO TWO GROUPS: FIRST GROUP, COMPRISING THE LAST 158 PATIENTS THAT USED THE CONVENTIONAL TECHNIQUE OF LPLD, AND SECOND GROUP, COMPRISING THE FIRST 182 PATIENTS USING THE HPSD TECHNIQUE. CLINICAL CHARACTERISTICS OF EACH GROUP ARE DESCRIBED IN TABLE 1. THE GOAL OF THE STUDY WAS TO DOCUMENT, ANALYZE, AND DEFINE IF HEART RATE INCREASE (HRI) DURING A FIRST ATRIAL FIBRILLATION (AF) ABLATION WITH HIGH-POWER SHORT-DURATION (HPSD) COMPARING TO LOW-POWER LONG-DURATION (LPLD) CAN IMPACT ON OUTCOME, INCLUDING RECURRENCE, IN A LONG-TERM FOLLOW-UP ANALYSIS. THREE PSEUDOANEURYSMS AND TWENTY-EIGHT GROIN HEMATOMAS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97205 AGILIS NXT INTRODUCER, UNKNOWN Introducer, catheter DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other