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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Heart Block (4444); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following was published in the pediatric cardiologyy (2022) 43:1695¿1703.Titled ¿the first evaluation of remote magnetic navigation-guided pediatric ventricular arrhythmia ablation", anna m.E.Noten.Received: 10 january 2022 / accepted: 28 march 2022 / published online: 29 april 2022.This single-center, retrospective study, investigated all consecutive ca procedures using rmn or manual-guided rf techniques in children (aged<18 years) as treatment of documented va (including pvc or vt) between the 1st of january 2008 until 31th of december 2020.We excluded patients in whom cross-over between ca techniques occurred.Outcomes were compared between two groups, based on the ablation technique used: conventional manual-guided rf ablation (man) or rmn-guided rf ablation (rmn).All patients scheduled for va ablation were distributed from the waiting list based on availability to the rmn-equipped or the conventional ep laboratory.Accordingly, ablation was performed either using rmn or using conventional man.The procedures were performed over the entire study duration by the same senior electrophysiologist group with the assistance of fellows, trained for manual catheter navigation as well as for rmn.The attending physicians performed rmn and man procedures in equal distribution.The primary endpoint for pvc ablation was>90% reduction in pvc burden in comparison to baseline during long-term follow-up as measured by holter continuous rhythm observation.The primary endpoint for vt ablation was absence of recurrence of sustained vt during long-term follow-up.We also analyzed the following secondary endpoints: procedural parameters (including fuoroscopy dosages), acute procedure success, redo procedure rates, and complication rates.The study protocol conforms to the ethical guidelines of the 1975 declaration of helsinki.The local medical ethics committee determined this study was not subject to the dutch medical research involving human subjects act (wmo).The need for individual consent was waived by the local medical ethical committee.Temporary av block that resolved completely after the procedure.

Manufacturer Narrative

One minor complication in a patient treated with rmn who had temporary av block, that resolved completely after the procedure.Tacticath se devices are not used during rmn procedures, only during man procedures.Therefore the tacticath se would not be associated with the av block that occurred, making this event not reportable.

Event Description

One minor complication in a patient treated with rmn who had temporary av block, that resolved completely after the procedure.Tacticath se devices are not used during rmn procedures, only during man procedures.Therefore the tacticath se would not be associated with the av block that occurred, making this event not reportable.

• 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: 15828136
• MDR Text Key: 303949778
• Report Number: 3005334138-2022-00628
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 12/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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: 11/21/2022
• 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