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

Model Number	A-TCSE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	02/28/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the tacticath se catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
The patient underwent an atrial fibrillation (af) procedure on (b)(6) 2026.The patient presented to the emergency department at the hospital on (b)(6) 2026 with chest pain, fever, and skin mottling.The patient displayed an altered consciousness state with glasgow score of 11.A ct scan showed mediastinal air bubbles and intra cardiac air bubbles which lead to an atrioesophageal fistula.The fistula was located posterior to the left superior pulmonary vein ostium.Cardiac surgery was performed where a patch was placed.The patient died on (b)(6) 2026.A non-abbott temperature probe (proact ref.(b)(4)) had been used during the af procedure.The physician does not know what caused the fistula.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system and the case study were returned.The log file analysis concluded that the tacticath se catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation and contact force measurements were displayed throughout the duration of the log files.Following review of the case study, it was determined that the maximum and average power exceeded the recommended values in the tacticath contact force ablation catheter, sensor enabled instructions for use (ifu); however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ABBOTT 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): ABBOTT 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24743950
• Report Number: 3008452825-2026-00181
• Device Sequence Number: 18337799
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)11167529(17)281130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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 Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 11167529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 130 KG