BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 17778301 · Received September 19, 2023

    Report

    Report Number
    3005334138-2023-00425
    Event Type
    Injury
    Date Received
    September 19, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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 PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY 46.7: 563-573. JOHN WILEY AND SONS INC (JUL 2023) "OUTCOMES OF ADJUNCT POSTERIOR WALL ISOLATION IN ATRIAL FIBRILLATION PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES"; ARYANA, ARASH THE STUDY COHORT CONSISTED OF CONSECUTIVE PATIENTS WITH CIED UNDERGOING A FIRST-TIME CRYOBALLOON ABLATION FOR SYMPTOMATIC AF BETWEEN 9/2016 AND 12/2020. DUE TO CHANGES IN OUR EVOLVING ABLATION PRACTICES, PVI WAS MORE FREQUENTLY PERFORMED DURING THE INITIAL PHASE OF THE STUDY, WHEREAS THE PVI+PWI CASES WERE FROM THE LATTER PERIOD. NONETHELESS, BOTH PROCEDURE TYPES WERE PERFORMED BY OPERATORS WHO WERE HIGHLY EXPERIENCED WITH CRYOBALLOON ABLATION, POSSESSING =24 MONTHS OF EXPERIENCE WITH CRYOBALLOON PVI AT THE TIME WHEN PVI ONLY PROCEDURES WERE IMPLEMENTED AND =24 MONTHS OF EXPERIENCE WITH CRYOBALLOON PVI+PWI AT THE TIME WHEN THIS TECHNIQUE WAS PERFORMED. ONLY PATIENTS WITH CIEDS CAPABLE OF CONTINUOUS AF MONITORING WERE INCLUDED. THESE CONSISTED OF IMPLANTABLE LOOP RECORDERS, OR PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES WITH AN ATRIAL LEAD. ACUTE PVI WAS ACHIEVED IN ALL PATIENTS USING CRYOBALLOON ABLATION. COMPARED TO PVI ALONE, PVI+PWI WAS ASSOCIATED WITH LONGER CRYOABLATION, FLUOROSCOPY, AND TOTAL PROCEDURE TIMES. ADJUNCT RADIOFREQUENCY WAS REQUIRED TO COMPLETE PWI IN 29/77 PATIENTS. ADVERSE EVENTS WERE SIMILAR WITH PVI ALONE VERSUS PVI+PWI. BUT AT 24 ± 7 MONTHS OF FOLLOW-UP, NOT ONLY CRYOBALLOON PVI+PWI WAS ASSOCIATED WITH IMPROVED FREEDOM FROM RECURRENT AF AND ALL ATRIAL TACHYARRHYTHMIAS IN PATIENTS WITH PERSAF, CRYOBALLOON PVI+PWI ALSO YIELDED GREATER FREEDOM FROM AF AND ALL ATRIAL TACHYARRHYTHMIAS IN THOSE WITH PAF. ADDITIONALLY, PVI+PWI WAS ASSOCIATED WITH HIGHER REDUCTIONS IN ATRIAL TACHYARRHYTHMIA BURDEN, NEED FOR CARDIOVERSION AND REPEAT CATHETER ABLATION, AND A LONGER TIME-TO-ARRHYTHMIA RECURRENCE IN BOTH PERSAF AND PAF PATIENTS. PERICARDIAL EFFUSION AND ACUTE PHRENIC NERVE PALSY WERE NOTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747877 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 Unknown Life Threatening