BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 21536698 · Received March 6, 2025

    Report

    Report Number
    3008452825-2025-00098
    Event Type
    Injury
    Date Received
    March 6, 2025
    Report Date
    March 27, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    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.

    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 JACC: CLINICAL ELECTROPHYSIOLOGY 10.12: 2711-2724. ELSEVIER INC. (DEC 1, 2024) "NOVEL OMNIPOLAR MAPPING TECHNOLOGY FOR EFFECTIVE SUPERIOR VENA CAVA ISOLATION: A RANDOMIZED CLINICAL TRIAL" OGURI, NAOTO MD. IN THIS STUDY, WE EMPLOYED THE INNOVATIVE OMNIPOLAR MAPPING TECHNOLOGY (OT) TO DISCERN THE RA-SVC CONNECTION AND COMPARED CLINICAL OUTCOMES WITH THOSE FROM CM. SIXTY-TWO PATIENTS UNDERGOING SVC ISOLATION WERE RANDOMLY ASSIGNED IN A 1:1 RATIO TO EITHER THE OT OR CM GROUP. NO SIGNIFICANT DIFFERENCES IN THE BASELINE CHARACTERISTICS WERE OBSERVED BETWEEN THE TWO GROUPS. WE ASSESSED THE EFFICACY AND SAFETY OF BOTH GROUPS. BOTH GROUPS SHOWED COMPARABLE ACUTE SUCCESS RATES (96%) IN SVC ISOLATION, BUT THE PROCEDURE IN THE OT GROUP REQUIRED FEWER RADIOFREQUENCY (RF) APPLICATIONS AND SHORTER PROCEDURE TIME. THE OVERALL ABSORBED DOSE WAS NOTABLY LOWER IN THE OT GROUP. TWO PHRENIC NERVE INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593627 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening