BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 21076610 · Received January 5, 2025

    Report

    Report Number
    3008452825-2025-00006
    Event Type
    Injury
    Date Received
    January 5, 2025
    Report Date
    February 26, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ARRHYTHMIA, IN AN ARTICLE TITLED "PREDICTORS OF LONG-TERM SUCCESS AFTER HIGH-DENSITY MAPPING-GUIDED SUBSTRATE ABLATION PROCEDURES FOR VENTRICULAR TACHYCARDIA IN PATIENTS WITH ISCHEMIC CARDIOMYOPATHY"; 2024;40:1442¿1451.BALT, J.C., DOI:10.1002/JOA3.13175. OBSERVATIONAL COHORT STUDY INCLUDES PATIENTS WITH ISCHEMIC HEART DISEASE WHO UNDERWENT HD MAPPING- GUIDED SUBSTRATE ABLATION OF VENTRICULAR TACHYCARDIA. BASELINE AND PROCEDURAL CHARACTERISTICS WERE ASSOCIATED WITH OUTCOMES AFTER VENTRICULAR TACHYCARDIA ABLATION. THE WAS ONE OCCURRENCE OF A VASCULAR COMPLICATION AND 2 CARDIAC TAMPONADES. NO PERMANENT SEQUELAE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963040 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 AGILIS NXT INTRODUCER.