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

Model Number	A-TFSE-FJ
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction ablation procedure, connection issues resulted in a procedural delay.The catheter was connected to the tactisys system but it was noted that the catheter was unable to show a force reading.Troubleshooting included attempting to disconnect the fiber optic portion of the catheter, but the fiber optic was unable to be removed.The catheter was removed from the patient and the lever was depressed using forceps and another attempt was used to remove the catheter to no avail.Multiple attempts were made to remove the fiber optic cable and eventually pliers were used to remove the fiber optic cable.A new tactisys quartz was connected and a new catheter was connected to the dws, which resolved the issue.The procedure was completed successfully with no patient consequences.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.Corrected data: d3, d4, h4.One bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported contact force issue and physical connection issue could not be confirmed.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 optical connector was able to be connected and disconnected from the tactisys with no anomalies noted.The deformable body thermocouple met specifications during electrical testing with no open or short circuits detected.The batch 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 corrected device manufacturing information.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24387857
• Report Number: 2184149-2026-00040
• Device Sequence Number: 13314043
• Product Code: OAE
• UDI-Device Identifier: 05415067034618
• UDI-Public: (01)05415067034618(10)10711022(17)280131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/26/2026

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-FJ
• Device Catalogue Number: A-TFSE-FJ
• Device Lot Number: 11043238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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