BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 23211147 · Received October 3, 2025

    Report

    Report Number
    3008452825-2025-00494
    Event Type
    Injury
    Date Received
    October 3, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. 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.

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY (2025) 36:1293¿1302, WILEY PERIODICALS LLC. "REAL-WORLD IMPACT OF STEERABLE SHEATHS FOR PAROXYSMAL ATRIAL FIBRILLATION CATHETER ABLATION: THE INSIGHT STUDY"; YASUO OKUMURA THIS NON-RANDOMIZED, MULTICENTER, RETROSPECTIVE COHORT STUDY (INSIGHT) AIMED TO DETERMINE THE REAL-WORLD IMPACT OF THE VIZIGO SHEATH ON PROCEDURAL EFFICIENCY, CLINICAL EFFECTIVENESS, AND SAFETY IN PAROXYSMAL AF (PAF) CATHETER ABLATION. CONSECUTIVE ADULTS WHO UNDERWENT DE NOVO RADIOFREQUENCY (RF) ABLATION FOR PAF WITH A NON-VIZIGO SHEATH (JANUARY 2019¿JULY 2021) OR VIZIGO SHEATH (JANUARY 2020¿JULY 2021) WERE INCLUDED. PROCEDURAL CHARACTERISTICS, PRIMARY ADVERSE EVENTS (PAES), AND 12-MONTH EFFECTIVENESS (FREEDOM FROM REPEAT ABLATION OR RECURRENT ATRIAL ARRHYTHMIA) WERE EVALUATED. OF 199 PATIENTS INCLUDED, 97 HAD ABLATION WITH A VIZIGO SHEATH AND 102 WITH A NON-VIZIGO SHEATH. SIGNIFICANTLY SHORTER MEAN TIMES WERE ACHIEVED IN THE VIZIGO VS. NON-VIZIGO GROUP FOR TIME TO LEFT PVI, RIGHT PVI, TOTAL PVI, AND FLUOROSCOPY TIME. MEAN FLUOROSCOPY DOSE WAS SIGNIFICANTLY LOWER WITH VIZIGO VS. NON-VIZIGO SHEATHS. CATHETER STABILITY WAS COMPARABLE BETWEEN GROUPS. PAE RATES WERE SIMILAR IN THE VIZIGO (3.1%) AND NON-VIZIGO (4.9%) GROUPS. FREEDOM FROM REPEAT ABLATION AND RECURRENT ATRIAL ARRHYTHMIA AT 12 MONTHS WERE ALSO SIMILAR IN THE TWO GROUPS. 4 MAJOR VASCULAR ACCESS/BLEEDING WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905066 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other