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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One uni-directional, curve f, tactiflex ablation catheter, sensor enabled was received for evaluation.No visual anomalies were noted.Microscopic inspection of the distal tip revealed no anomalies.The reported ¿catheter not connected¿ 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
During an atrial tachycardia procedure, there were communication issues with the advisor hd grid x catheter and the tactiflex ablation catheter resulting in a delay.It was noted that the advisor hd grid x catheter could not be visualized using port 8 and that a magnetic sensor error was displayed.The cable was exchanged, without resolution.The catheter was exchanged, and connected into port 7 which resolved the issue.However, the tactiflex catheter also was not being recognized and displayed an error stating "catheter not connected".The issue was resolved by replacing the catheter.The procedure was completed without adverse patient consequences.

• 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: 23786717
• Report Number: 3008452825-2025-00626
• Device Sequence Number: 13375169
• Product Code: OAE
• UDI-Device Identifier: 05415067034670
• UDI-Public: (01)05415067034670(10)10879406(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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 Expiration Date: 04/30/2026
• Device Model Number: A-TFSE-F
• Device Catalogue Number: A-TFSE-F
• Device Lot Number: 10879406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SE.
• Patient Age: 54 YR
• Patient Sex: Unknown