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	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fracture that was noted during analysis.During an atrial fibrillation (apoplexy) procedure, the catheter showed no pressure.A new catheter was used to continue the procedure, which was successfully completed without harm to the patient.
Additional Manufacturer Narrative
One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.The catheter shaft material had been fractured 0.3610¿ proximal to the distal tip, just distal to electrode ring 3.No other visual anomalies were noted.Microscopic inspection of the distal shaft fracture between electrode rings 2 and 3 revealed that internal components were protruding through the fracture.The batch 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-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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24561503
• Report Number: 3008452825-2026-00119
• Device Sequence Number: 9422155
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: (01)05415067027634(10)10669639(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/10/2026

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: 06/30/2026
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 10669639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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