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

Model Number	A-TCSE-FJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Shock (2072); Cardiogenic Shock (2262)
Date of Event	10/28/2024
Type of Reportable Event	Death
Event or Problem Description
The patient presented with acute coronary syndrome during the electrophysiological study and ablation procedure, evolving with sustained ventricular tachycardia, ventricular fibrillation, cardiogenic shock, cardiorespiratory arrest and expired.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported acute coronary syndrome, evolving with sustained ventricular tachycardia, ventricular fibrillation, cardiogenic shock, cardiorespiratory arrest, and subsequent patient death remains unknown.
Event or Problem Description
The patient presented with acute coronary syndrome during the electrophysiological study and ablation procedure, evolving with sustained ventricular tachycardia, ventricular fibrillation, cardiogenic shock, cardiorespiratory arrest and expired.No ablation was performed prior to the occurrence of acute coronary syndrome.There were no alleged device deficiencies or performance issues with any abbott device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20600165
• Report Number: 3008452825-2024-00644
• Device Sequence Number: 8797216
• Product Code: OAE
• UDI-Device Identifier: 05415067027665
• UDI-Public: (01)05415067027665(10)10241409(17)250831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: A-TCSE-FJ
• Device Catalogue Number: A-TCSE-FJ
• Device Lot Number: 10241409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown