BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 18684739 · Received February 12, 2024

    Report

    Report Number
    3008452825-2024-00086
    Event Type
    Injury
    Date Received
    February 12, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTD
    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

    . THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 34.12: 2452-2460. JOHN WILEY AND SONS INC. (DEC 2023) IN AN ARTICLE TITLED "PREDICTORS OF PULMONARY VEIN NON-RECONNECTION IN THE SECOND PROCEDURE AFTER ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION AND ITS IMPACT ON THE OUTCOME." INTRODUCTION: ALTHOUGH FIRST-PASS ISOLATION (FPI) OF THE PULMONARY VEIN (PV) HAS BEEN SUGGESTED AS A MARKER FOR PV ISOLATION (PVI) DURABILITY, IT HAS NOT BEEN CONFIRMED. NON-PV ATRIAL FIBRILLATION (AF) TRIGGERS WERE THE MAIN TARGET IN PATIENTS WITHOUT PV RECONNECTION IN THE SECOND ABLATION PROCEDURE, BUT THE OUTCOME WAS UNCLEAR. WE AIMED TO VALIDATE FPI AS A MARKER OF PVI DURABILITY AND EVALUATE THE OUTCOME AFTER THE SECOND PROCEDURE IN PATIENTS WITHOUT PV RECONNECTION BY COMPARING IT TO THOSE WITH RECONNECTION. METHODS: AMONG THE 2087 PATIENTS UNDERGOING THE FIRST ABLATION INDEX-GUIDED RADIOFREQUENCY AF ABLATION, 309 WITH ATRIAL TACHYARRHYTHMIAS (ATS) RECURRENCE AND UNDERGOING THE SECOND PROCEDURE WERE STUDIED. CLINICAL CHARACTERISTICS AND OUTCOMES WERE COMPARED BETWEEN THE PATIENTS WITHOUT PV RECONNECTION (PV NON-RECONNECTION GROUP, N = 142) AND WITH RECONNECTION (PV RECONNECTION GROUP, N = 167). THERE WAS ONE REPORTED EVENT OF TAMPONADE AND THREE EVENTS OF PHRENIC NERVE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298841 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL, COSTA RICA LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown