MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

Additional information confirmed no abbott devices contributed to event.

Event Description

Additional information confirmed no abbott devices contributed to event.

Manufacturer Narrative

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.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17766757
• MDR Text Key: 323643255
• Report Number: 3005334138-2023-00426
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention