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

Model Number	A-TCSE-F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis.Pulmonary vein ablation and cti was performed.A transesophageal echocardiogram was not performed because it was not possible to insert the probe into the patient's mouth.The transesophageal echo was not performed because it was impossible to insert the probe into the patient's mouth.The patient had a patent foramen ovale, through which the catheters were inserted.While ablating on the cti, a steam pop was noted.A cardiac ultrasound was done at the end of the procedure which was negative.Two to four hours after the procedure, the patient's blood pressure decreased.An echocardiogram was done which revealed a pericardial effusion.A pericardiocentesis was performed, 500ml was removed and the patient stabilized.The physician thinks the effusion is due to the steam pop on the cti.
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 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.Force measurements were recorded during ablation that exceeded the recommended values in the tacticath contact force ablation catheter, sensor enabled instructions for use (ifu).In addition, information from the field indicates that ablations were performed with an rf power up to 40w.The ifu warns that "application of rf energy at a power higher than 30w is associated with a higher likelihood of audible steam pop occurrence" and that "too high rf power during ablation may lead to perforation caused by steam pop." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Due to unknown procedural conditions, 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¿ UNID CURVE 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: 23304039
• Report Number: 3008452825-2025-00513
• Device Sequence Number: 16000782
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: (01)05415067027696(10)10415442(17)251231
• 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
• Report Date (Section B): 12/22/2025

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: 12/31/2025
• Device Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 10415442
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown