MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TCSE-D
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there were temperature issues with three catheters resulting in a delay.The first catheter was inserted into the patient, and the temperature was lower than expected.Ablation was initiated on the left posterior wall of the left atrium, and the temperature dropped to 28c.An attempt was made to reinsert the connector cable, with no resolution.The pn cable was exchanged, and the ablation was initiated again; but the temperature dropped below 30c.The rf ablation generator was exchanged, and a second ablation was attempted, with no resolution.Troubleshooting was also done by increasing energy delivery beyond 10 seconds, with no resolution.The catheter was exchanged and inserted into the patient and the temperature remained lower than expected without ablation and pressure readings were not displayed accurately.The connector cable was re-inserted, with no resolution.The case was restarted, but the issue remained.The tactisys system was exchanged, but the issue persisted.The catheter was exchanged again, and the baseline temperature remained low prior to ablation.When ablation was attempted, the temperature dropped below 30c.Reducing the priming time and lowering the saline flow rate before another energy delivery attempt resulted in a temperature drop to 32c.An attempt was also made to attempt for energy delivery in a non-contact state with a saline flow rate of 2 ml/min, which led to a maximum temperature rise of 35c.As the temperature was still lower than expected, the catheter was exchanged again, and the issue was resolved.The temperature did rise to 36c and the procedure was completed with no adverse patient health consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve d, tacticath sensor enabled contact force ablation catheter was received for evaluation.One video was also submitted for evaluation.The video submitted with the returned device shows an ensite screen and when ablation starts temperature is shown to decrease.However, the device met specifications during temperature testing and flow rate testing.In addition, electrode 1 and the tip thermocouple met specifications during electrical testing with no open or short circuits detected.A simulated ablation was performed, and no temperature or power delivery anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported temperature issue and subsequent delay remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: 21902036
• Report Number: 3008452825-2025-00191
• Device Sequence Number: 8713495
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: (01)05415067027689(10)10315597(17)250930
• 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): 05/09/2025

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: 09/30/2025
• Device Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 10315597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Sex: Unknown