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 Codes	Communication or Transmission Problem (2896); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an svt procedure, communication and impedance issues with the catheter resulted in a procedural delay.The ablation catheter was removed following best practices and connected to the coolpoint pump, the tactisys, and the ensite x se port.The catheter was flushed and inspected before inserting into the patient.On the mapping system, the catheter was visualized, the catheter signals were seen, and the contact force was able to be zeroed.However, it was noted on the generator metrics that the impedance readings were 200 ohms.The ampere message stated, "catheter not connected." the tactiflex rf cable (from tactisys to ampere) was replaced and the impedance now read 999 on the mapping system and the ampere continued to not recognize the catheter connection.The ampere and tactisys were both power cycled with no resolution.The ampere was then replaced but the issue persisted.The catheter was replaced which resolved the issue and the procedure was completed with no adverse consequences to the patient.
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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.One uni-directional, curve f, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported ampere recognition and impedance issue could not be confirmed.Electrode 1 and the tip thermocouple met specifications during electrical testing with no open or short circuits detected.In addition, the tip thermocouple temperature reading increased with exposure to heat.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
The device was received for evaluation.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: 23393096
• Report Number: 3008452825-2025-00531
• Device Sequence Number: 18686943
• Product Code: OAE
• UDI-Device Identifier: 05415067034670
• UDI-Public: (01)05415067034670(10)10758992(17)280229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/10/2026

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-F
• Device Catalogue Number: A-TFSE-F
• Device Lot Number: 10758992
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/15/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/18/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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
• Patient Sex: Female