BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 17766757 · Received September 18, 2023

    Report

    Report Number
    3005334138-2023-00426
    Event Type
    Injury
    Date Received
    September 18, 2023
    Report Date
    October 31, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 OF PERICARDIAL EFFUSION REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CONFIRMED NO ABBOTT DEVICES CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE HEART RHYTHM 20.9: 1279-1286. ELSEVIER B.V. (SEP 2023): "CLINICAL IMPACT OF AGING ON OUTCOMES OF CARDIO NEURO ABLATION FOR REFLEX SYNCOPE OR FUNCTIONAL BRADYCARDIA: RESULTS FROM THE CARDIO EURO ABLATION: PATIENT SELECTION, IMAGE INTEGRATION AND OUTCOMES¿THE ELEGANCE MULTICENTER STUDY", FRANCIA, PIETRO; FRANCIA ET AL; DOI: HTTP://DX.DOI.ORG/10.1016/J.HRTHM.2023.06.007 A RETROSPECTIVE STUDY OF 60 PATIENTS UNDERWENT CNA FROM FEBRUARY 2021 TO FEBRUARY 2023, 60 PATIENTS. THE STUDY IS A MULTICENTER STUDY THAT ASSESSED CNA IN PATIENTS WITH RECURRENT VVS OR CSS AND PATIENTS WITH SYMPTOMATIC FUNCTIONAL SINUS BRADYCARDIA OR ADVANCED AV BLOCK IN WHOM A PACEMAKER IMPLANT WAS CONSIDERED. CARDIO NEURO ABLATION (CNA) IS A NEW APPROACH FOR TREATING VASOVAGAL SYNCOPE (VVS),1¿4 CAROTID SINUS SYNDROME (CSS),5 SYMPTOMATIC SINUS BRADYCARDIA,6 AND ATRIOVENTRICULAR (AV) BLOCKS7,8 CAUSED BY AUTONOMIC IMBALANCE. EVIDENCE SUGGESTS THAT AUTONOMIC CONTROL IN YOUNGER INDIVIDUALS IS CHARACTERIZED BY THE PREDOMINANCE OF VAGAL ACTIVITY, WHEREAS IN OLDER INDIVIDUALS, SYMPATHETIC TONE IS MORE PROMINENT.9 CONSISTENT WITH THIS NOTION, THE EXTENT OF VAGAL EXCITATION DURING CNA VARIES WITH AGE, WITH YOUNGER PATIENTS EXHIBITING GREATER VAGAL RESPONSES.10 THEREFORE, IN OLDER PATIENTS SYMPTOMATIC BRADYARRHYTHMIA IS MORE LIKELY CONSIDERED TO BE RELATED TO ORGANIC DYSFUNCTION OF SINUS OR AV NODES RATHER THAN SYMPATHOVAGAL IMBALANCE.11,12 HOWEVER, THE EXACT EFFECT OF AGE ON THE EFFICACY OF CNA IN PATIENTS WITH REFLEX SYNCOPE IS NOT YET FULLY UNDERSTOOD. A SINGLE STUDY REPORTED THAT YOUNGER PATIENTS (50 YEARS OF AGE) WITH FUNCTIONAL SINUS BRADYCARDIA TREATED WITH CNA HAVE BETTER CLINICAL OUTCOMES AND FASTER RECOVERY OF AUTONOMIC BALANCE THAN OLDER PATIENTS. HOWEVER, THERE HAS NOT BEEN A SYSTEMATIC ASSESSMENT OF THE IMPACT OF AGING ON CNA CANDIDACY AND OUTCOMES IN PATIENTS PRESENTING WITH REFLEX SYNCOPE OR SYMPTOMATIC FUNCTIONAL BRADYARRHYTHMIA. AS CURRENT GUIDELINES ONLY RECOMMEND PACING FOR RECURRENT REFLEX SYNCOPE IN PATIENTS OLDER THAN 40 YEARS AND PACING HAS BEEN MOSTLY USED IN PATIENTS AGED 60 YEARS, DETERMINING THE EFFICACY OF CNA ACROSS THESE AGE CATEGORIES IS PARTICULARLY RELEVANT. THIS STUDY AIMED TO EVALUATE THE IMPACT OF AGING ON THE DIAGNOSTIC WORKUP FOR CNA CANDIDACY AND ON THE EFFICACY OF CNA AS A TREATMENT FOR VVS, CSS, AND SEVERE FUNCTIONAL SINUS BRADYCARDIA OR ADVANCED AV BLOCK. ONE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT WAS DRAINED THE FOLLOWING DAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION CONFIRMED NO ABBOTT DEVICES CONTRIBUTED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257348 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 Other| R