BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 18613204 · Received January 31, 2024

    Report

    Report Number
    3008452825-2024-00065
    Event Type
    Injury
    Date Received
    January 31, 2024
    Report Date
    March 1, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ESOPHAGEAL, PERIESOPHAGEAL, AND VAGAL NERVE INJURIES REMAIN UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 35.1: 86-93. JOHN WILEY AND SONS INC. (JAN 2024). IN AN ARTICLE TITLED "PULSED-FIELD ABLATION DOES NOT INDUCE ESOPHAGEAL AND PERIESOPHAGEAL INJURY¿A NEW ESOPHAGEAL SAFETY PARADIGM IN CATHETER ABLATION OF ATRIAL FIBRILLATION", DIRK GROSSE MEININGHAUS MD; DOI: 10.1111/JCE.16132. BETWEEN DECEMBER 2022 AND FEBRUARY 2023, 20 PATIENTS UNDERGOING PFA (FARAPULSE, BOSTON SCIENTIFIC) FOR ATRIAL FIBRILLATION (AF) WERE STUDIED AND COMPARED WITH A PREVIOUS COHORT OF 57 PATIENTS WHO UNDERWENT THERMIC PVI. FOLLOWING PFA-PVI, NONE OF THE PATIENTS HAD MUCOSAL LESIONS, FOOD RETENTION, OR ABLATION-INDUCED VAGAL NERVE INJURY; FOUR PATIENTS SHOWED PERIESOPHAGEAL EDEMA. IN CONTRAST TO THERMIC ABLATION TOOLS, PFA IS NOT ASSOCIATED WITH RELEVANT ESOPHAGEAL AND PERIESOPHAGEAL INJURY, AND MIGHT, THEREFORE, REDUCE OR ELIMINATE THE RISK OF POTENTIALLY LETHAL AEF IN INTERVENTIONAL TREATMENT OF AF. THE ETIOLOGY OF ABLATION-INDUCED PERIESOPHAGEAL EDEMA IS UNKNOWN BUT HAS NOT BEEN SHOWN TO BE RELATED TO LESION PROGRESSION. FOLLOWING ABLATION WITH THERMIC ENERGY SOURCES, ESOPHAGEAL OR PERIESOPHAGEAL INJURIES WERE OBSERVED IN THIRTY THREE PATIENTS. VAGAL NERVE INJURIES WERE OBSERVED IN SEVENTEEN PATIENTS FOLLOWING THERMIC ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421239 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 Other