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

Model Number	A-TCSE-DD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Shaft damage was noted approximately 1.2¿ proximal to the distal tip.No other visual anomalies were noted.Microscopic inspection of the distal shaft revealed a portion of the activation wire was protruding through the shaft material at the location of the aforementioned shaft damage.The reported deflection issue was confirmed.The device no longer deflected in the right d direction when actuating the steering mechanism.The tension knob functioned as intended and the shaft retained its curve shape when deflected in the left d direction (autolock).Further investigation revealed that the right d curve activation wire was fractured within the deflectable shaft and a portion of the activation wire was protruding through the shaft damage.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured activation wire remains unknown.
Event or Problem Description
This report is to advise of a fracture with a protruding wire found in the catheter shaft during analysis.During the afl procedure, after ablation for a period of time through the adjustable curved sheath, the catheter could no longer bend to the other side.After replacing the catheter, the procedure proceeded smoothly without any adverse consequences to the patient.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-D
• 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: 24457640
• Report Number: 3008452825-2026-00089
• Device Sequence Number: 15954333
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: (01)05415067027634(10)10740875(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
• Report Date (Section B): 02/26/2026

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 Expiration Date: 07/31/2026
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 10740875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• 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: 02/13/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown