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 Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a paroxysmal supraventricular tachycardia (psvt) procedure, a contact force issue occurred with the tacticath ablation catheter resulting in a delay.Contact force was displayed as expected initially.After rf was applied, the catheter was pulled out to observe for ten minutes.However, when the catheter was reinserted into the right atrium again to consolidate ablation, it was noted that the ensite mapping system displayed an error message stating: "no contact force information available".The connections were checked, the tactisys and mapping system were restarted, but the issue was not resolved.The catheter was then exchanged which resolved the issue and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.The reported event of a contact force issue was confirmed.No contact force was displayed when the returned device was connected to the tactisys quartz unit.An optical signal loss error were displayed, and optical fiber 2 no longer met specifications for optical properties.Further investigation revealed that the backfill adhesive within the catheter shaft had been fractured between electrode rings 2 and 3.Optical fiber 2 and the deformable body thermocouple (tc2) wires were determined to be fractured at the location of the fracture in the backfill adhesive, consistent with the observed error messages, the detected open circuit, and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 23675643
• Report Number: 3008452825-2025-00628
• Device Sequence Number: 9661619
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10719036(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/23/2025

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: 07/31/2026
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 10719036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/29/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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