MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TFSE-DD
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, a temperature problem occurred which caused a delay.During an atrial fibrillation procedure for atrial flutter (afl), rf delivery was performed at the cti first.The temperature setting was 35w and temperature control was activated occasionally, but the output power increased.Due to the anatomy of the pouch, temperature control was activated and the procedure continued.However, the afl did not stop, and rf delivery was performed successfully to stop the afl.When approaching the left atrium and starting rf delivery at the pulmonary vein reconduction site (at 50w), the output did not increase; the temperature and output fluctuated on the generator waveforms of the ensite.The catheter was then replaced and the procedure was completed with no adverse consequences to the patient.A procedure delay of approximately 3 to 4 hours occurred.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-d, tactiflex ablation catheter, sensor enabled was received for evaluation.The device was returned due to power delivery and unexpected temperature control issues.A simulated ablation was performed and no temperature or power delivery anomalies were noted.Further inspection of the distal electrode indicated the tip thermocouple was inadequately bonded within the distal tip well, consistent with the reported event.The catheter met specifications during electrical testing and irrigation flow testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information and analysis, the distal electrode indicated the tip thermocouple was inadequately bonded which may have contributed to the reported temperature issue and subsequent delay.The device inadequate bond is consistent with a design related issue.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19018485
• Report Number: 3008452825-2024-00181
• Device Sequence Number: 12747523
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: (01)05415067034557(10)9073212(17)240430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P220013
• 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): 05/02/2024

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: 04/30/2024
• Device Model Number: A-TFSE-DD
• Device Lot Number: 9073212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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