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

Model Number	A-TFSE-D
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pvc procedure, temperature issues with the catheter resulted in the cancellation of the procedure.After the first seven lesions were created, five subsequent lesions were stopped by the ampere generator due to the temperature cutoff being reached.The error message "measured temperature higher than programmed limit" was displayed.The irrigation was increased to 20 ml/min, but the issue was not resolved.After around twelve lesions, none of the lesions were successful.The catheter was not exchanged.There were no adverse consequences to the patient and a new pfa procedure was scheduled due to the inability to ablate.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve d, tactiflex ablation catheter, sensor enabled was received for evaluation.A simulated ablation was performed, and the catheter displayed a high average temperature rise.Inspection of the distal tip determined the tct wires were fully encapsulated within the tip well.The catheter met specifications during electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.One uni-directional, curve d, tactiflex ablation catheter, sensor enabled was received for evaluation.The ensite automark files returned to product performance engineering were analyzed.Based on power and temperature plots for sessions corresponding to the complaint device, temperature would increase to a set limit after ablations were initiated causing the tempguard feature to titrate (reduce) power output, consistent with the reported event.A simulated ablation was performed, and the catheter displayed a high average temperature rise.Inspection of the distal tip determined the tct wires were fully encapsulated within the tip well.The catheter met specifications during electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
This report includes an updated analysis.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23450835
• Report Number: 3008452825-2025-00551
• Device Sequence Number: 18402179
• Product Code: OAE
• UDI-Device Identifier: 05415067034656
• UDI-Public: (01)05415067034656(10)10922625(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A-TFSE-D
• Device Catalogue Number: A-TFSE-D
• Device Lot Number: 10922625
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 11/24/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/23/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2025
• 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
• Patient Sex: Unknown