MAUDE Adverse Event Report: ABBOTT MEDICAL, COSTA RICA LTDA 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	08/30/2025
Type of Reportable Event	Death
Event or Problem Description
One month following ablation procedure, patient developed an atrio-esophagus fistula.The original ablation procedure was in (b)(6) 2025 and the diagnosis occurred in (b)(6) 2025.The patient developed a fever.Echocardiogram showed some small bubbles.Ct scan showed some abnormalities between the esophagus and the left atrium.A patch was applied on both the esophagus and the left atrium.However, the patient is now deceased.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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Due to unknown procedural conditions, we are unable to conclusively determine the cause of the reported event, and the cause remains unknown.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.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 power, average power, and maximum contact force 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 atrio-esophagus fistula and patient death 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, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 23018181
• Report Number: 3008452825-2025-00448
• Device Sequence Number: 15895059
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10860968(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 10860968
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 04/27/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/20/2025; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown