MAUDE Adverse Event Report: ABBOTT MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TCSE-DF
Medical Device Problem Codes	Use of Device Problem (1670); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.A ¿catheter not detected¿ error message was displayed when the returned device was connected to the tactisys quartz, consistent with the reported event.Further investigation revealed the error message was due to fractures in the 19-pin connector flex circuit on the eeprom to pin 14 trace, consistent with the observed error message and with the reported event.Optical fibers 1-3 met specifications for optical properties.Electrodes 1-4 met specifications during electrical testing, however, the deformable body thermocouple read as an open circuit due to a fracture in the green tc2 wire within the 19-pin connector, consistent with the reported event.It was also determined that the tacticath contact force ablation catheter batch number 10178820 expired on 30 jun 2025 which was prior to the reported event date of 16 dec 2025.A review of distribution records confirmed that this product was distributed prior to its expiration date.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.The cause of the fractured tc2 wire, and the reported electrode signal issue remains unknown.The cause of the use of expired product is consistent with user error.
Event or Problem Description
This report is to advise of an expired catheter used during the procedure.During the af procedure, an expired catheter was used.The catheter was not visualized and the lsi parameters were not displayed.Although the catheter itself appeared on the screen, the window displaying the catheter-related contact force and lsi parameters appeared but did not show any data.The metal baseline was set, as was the distortion.The signals from the catheter electrodes did not appear on either the ensite system or the non-abbott (prucka) ep system.As a precaution, the connections between the tactisys and the tacticath catheter were checked; however, the issue could not be identified.The connection between the tactisys system and the generator was also checked, along with all amplifier connections.The catheter was used as described in the ifu.Ultimately, the issue was resolved by using a newly opened tactiflex catheter, which immediately displayed values on the icon after insertion.There were no patient consequences.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• 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: 24803596
• Report Number: 3008452825-2026-00196
• Device Sequence Number: 16122060
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10178820(17)250630
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P130026
• 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
• Report Date (Section B): 04/07/2026

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: 06/30/2025
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 10178820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2024
• 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 Sex: Male
• Patient Weight: 73 KG