BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER

    MDR report key: 23426449 · Received October 30, 2025

    Report

    Report Number
    3008452825-2025-00544
    Event Type
    Injury
    Date Received
    October 30, 2025
    Report Date
    October 30, 2025
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF PHRENIC NERVE PARALYSIS WAS 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. 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 EUROPEAN HEART JOURNAL (2025) 46, 3437¿3449. OXFORD UNIVERSITY PRESS; "ATRIAL AMYLOIDOSIS IDENTIFIED BY BIOPSY IN ATRIAL FIBRILLATION: PREVALENCE AND CLINICAL PRESENTATION"; KODAI SHINZATO. ATRIAL BIOPSY WAS PERFORMED ON 578 PATIENTS DURING AF ABLATION, WITH RIGHT VENTRICULAR BIOPSY CONDUCTED IN 385 PATIENTS. THE AMYLOID TYPE WAS ASSESSED USING IMMUNOHISTOCHEMISTRY. PATIENTS WERE CLASSIFIED INTO GROUPS OF ATRIAL BIOPSY¿DETECTED CA AND NON-CA, WITH AN ADDITIONAL 58 PATIENTS CLINICALLY DIAGNOSED WITH CA COMPRISING THE CLINICAL CA GROUP. 1 EVENT OF PHRENIC NERVE PARALYSIS WHICH RESOLVED ON ITS OWN WITHOUT INTERVENTION. THE PHYSICIAN ALLEGES THE ABLATION CATHETER CAUSED OR CONTRIBUTED TO PHRENIC NERVE PARALYSIS. THERE WERE NO PERFORMANCE ISSUES WITH THE ABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618188 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE VENUSA DE MEXICO S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening