MAUDE Adverse Event Report: ABBOTT 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-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During an atrial fibrillation pvi procedure in ensite x voxel mode, a pericardial effusion occurred which required a pericardiocentesis.Two transseptal punctures were performed as per standard for this procedure and while mapping the left atrium with the ablation catheter and an advisor fl mapping catheter, low blood pressure was observed.Transesophageal echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
Event or Problem Description
This report includes updated device batch/lot number, model, and associated manufacturing information.
Additional Manufacturer Narrative
Additional information: b5, d4, d9, g3, h2, h3, h4, 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 were returned.The log file analysis concluded that the tacticath se catheter performed as intended.The optical fibers met specifications 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.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this 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): 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: 24359233
• Report Number: 3008452825-2026-00062
• Device Sequence Number: 9887791
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10851512(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/18/2026

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: 10851512
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown