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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contractions procedure, there was a communication issue with the tactiflex catheter resulting in a delay.When the catheter was inserted into the heart and connected to the tacisys and ensite, the se indicator remained red and the navigation was not displayed.No error message was displayed.The catheter was reconnected to the ensite and the ensite was restarted, but the se function was not recognized.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h2, h3, h4, h6, h11.One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.No visual anomalies were noted.The catheter was connected to the tactisys quartz unit.Proprietary software was used to view the 10-pin eeprom payload, and no anomalies were noted.No open or short circuits were detected during electrical testing.Microscopic inspection of the distal shaft revealed no anomalies.The first use date of this device (as determined by the eeprom) and the reported event date do not match.The cause of this date discrepancy remains unknown.The reported event of a magnetic sensor issue could not be confirmed.The magnetic sensors met specifications during electrical testing with no open or short circuits detected, the 10-pin connector eeprom met programming specification.The device history records for each possible batch number (10600435 or 10685679) were reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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: 23458059
• Report Number: 3008452825-2025-00559
• Device Sequence Number: 18111759
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: (01)05415067034557(10)10600435(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/18/2026

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 Expiration Date: 10/31/2025
• Device Model Number: A-TFSE-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 10600435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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 Age: 35 YR
• Patient Sex: Male