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

Model Number	A-TFSE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contractions procedure, a pericardial effusion was noted on the rv/rvot free wall resulting in a pericardiocentesis to be performed.During the procedure, when ablation first came on, contact force on the ablation catheter showed 30g, and the generator metrics showed a change in impedance and power delivery.The patient remained stable but due to a suspicion of a perforation, fluoroscopy and intracardiac echo were performed which confirmed an effusion.By this time the perforation had already self-closed but a pericardiocentesis was performed to drain the effusion.The patient remaining stable throughout.There were no performance issues with any abbott device, and it is suspected that the anatomical area was very thin.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.When the returned device was connected to the tactisys quartz unit, optical fibers 1-3 met specifications for optical properties and contact force was displayed with no error messages noted.The magnetic sensors, both thermocouples, and electrodes 1-4 met specifications during electrical testing with no open or short circuits detected.In addition, the device met specifications during temperature testing and flow rate testing.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event of a pericardial effusion 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: 23780750
• Report Number: 3008452825-2025-00653
• Device Sequence Number: 10105660
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)10972864(17)280630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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-TFSE-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 10972864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 75 KG