BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23134223 · Received September 24, 2025

    Report

    Report Number
    3008452825-2025-00476
    Event Type
    Injury
    Date Received
    September 24, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABBOTT MEDICAL, COSTA RICA LTDA
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. AN EVENT OF A CARDIAC TAMPONADE AND A STROKE WERE REPORTED. 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 THE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY IN AN ARTICLE TITLED "EFFICACY OF ADDITIONAL EXTRA MAPPING-GUIDED SUBSTRATE ABLATION BEYOND PULMONARY VEIN ISOLATION IN PERSISTENT ATRIAL FIBRILLATION: THE ROTATE TRIAL ", TETSUMA KAWAJI, JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2025; 36:1999¿2010 HTTPS://DOI.ORG/10.1111/JCE.16772. ABSTRACT: INTRODUCTION: THERE ARE CURRENTLY NO ESTABLISHED EFFECTIVE ADDITIONAL SUBSTRATE ABLATION STRATEGIES BEYOND PULMONARY VEIN ISOLATION (PVI) FOR PERSISTENT ATRIAL FIBRILLATION (AF). OBJECTIVE: THIS RANDOMIZED CLINICAL TRIAL EVALUATED THE EFFICACY OF A NOVEL SUBSTRATE ABLATION TECHNIQUE USING THE EXTRA MAPPING SYSTEM, WHICH VISUALIZES ROTATIONAL ACTIVATION DURING AF RHYTHM. METHODS: THIS STUDY INCLUDED 80 PATIENTS UNDERGOING INITIAL CATHETER ABLATION FOR PERSISTENT AF. EIGHTY PATIENTS WHOSE AF PERSISTED AFTER PVI AND EXTRA MAPPING WERE RANDOMLY ASSIGNED IN A 1:1 RATIO TO EITHER PVI ALONE OR PVI PLUS EXTRA MAPPINGGUIDED SUBSTRATE ABLATION TARGETING AREAS WITH HIGH NON-PASSIVELY ACTIVATED RATIO(%NP)( = 35%)(EXTRA GROUP). THE PRIMARY OUTCOME MEASURE WAS RECURRENCE OF ATRIAL TACHYARRHYTHMIAS AFTER A 90-DAY BLANKING PERIOD POSTABLATION. RESULTS: POST-PVI EXTRA MAPPING ASSESSED A MEDIAN OF 36 SITES PER PATIENT IN BOTH ATRIA. BASELINE CHARACTERISTICS WERE COMPARABLE BETWEEN GROUPS. THE EXTRA GROUP SHOWED HIGHER EVENT-FREE SURVIVAL FROM THE PRIMARY OUTCOME COMPARED TO THEPVI ALONE GROUP (85.0% VS. 67.5% AT 1-YEAR, P=0.07). THIS FAVORABLE PROGNOSIS WAS MORE PRONOUNCED FOR PATIENTS WITH A LARGE ( =12 SITES) AREA OF ROTATIONAL ACTIVATION AREA (81.0% VS. 57.9% AT 1-YEAR, P = 0.01). MULTIVARIABLE ANALYSIS IDENTIFIED THE NUMBER EXTRA MAPPING-GUIDED SUBSTRATE ABLATION EMERGED AS A UNIQUE PROTECTIVE FACTOR (HR 0.38, 95%CI 0.13-0.99, P=0.047). CONCLUSION: WHILE THE REDUCTION IN ATRIAL TACHYARRHYTHMIA RECURRENCE OF PERSISTENT AF PATIENTS DID NOT REACH STATISTICAL SIGNIFICANCE, THE ADDITION OF EXTRA MAPPING¿-GUIDED SUBSTRATE ABLATION BEYOND PVI DEMONSTRATED PROMISING POTENTIAL, ESPECIALLY IN PATIENTS WITH LARGER ROTATIONAL ACTIVATION AREAS. THE INCIDENCE OF IN-HOSPITAL ADVERSE OUTCOMES AFTER THE INDEX ABLATION PROCEDURE WAS 2.5%, INCLUDING ONE CARDIAC TAMPONADE AND ONE ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393727 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention