MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TFSE-F
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of an atrial fibrillation procedure, a pericardial effusion occurred requiring a pericardiocentesis and protamine administration to stabilize the patient.Pulmonary vein ablation and cti was performed.A transesophageal echo was performed for transseptal puncture and ablation of 4 pulmonary veins was performed.At the end, when checking isolation of the veins with the mapping catheter, the contact force value of the ablation catheter was not available.An error message from the tactics on the ensite x indicated « no contact force signal or out of range.Check catheter optical connection.Contact abbott technical service ».The tactisys was turned off and the ablation catheter was disconnected.The tactisys was then turned on and the ablation catheter was reconnected which did not resolve the issue.The contact force value was indicated when the catheter was not deflected.Ablation was done without contact force in the right pulmonary veins.At the end of the procedure, the patient became hypotensive and an echocardiogram confirmed a pericardial effusion.A pericardiocentesis and protamine were administered which stabilized the patient.The patient left the operating room and remained stable.It is unknown how or when the pericardial effusion occurred.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve f, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported no contact force issue was confirmed.When the catheter was connected to the tactisys quartz unit, optical fiber 1 no longer met specifications for optical properties and no contact force was displayed.Further investigation revealed optical fiber 1 was fractured within the distal shaft, consistent with the detected optical signal issue and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured optical fiber remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23402853
• Report Number: 3008452825-2025-00510
• Device Sequence Number: 10047969
• Product Code: OAE
• UDI-Device Identifier: 05415067034670
• UDI-Public: (01)05415067034670(10)10978688(17)280630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P220013
• 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): 12/16/2025

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 Model Number: A-TFSE-F
• Device Catalogue Number: A-TFSE-F
• Device Lot Number: 10978688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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
• Patient Sex: Unknown