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-FJ
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacture ref: 3008452825-2024-00665.During an atrial fibrillation procedure, an output issue occurred causing a delay in procedure.It was noted that there was no rf delivery during ablation.The tactisys cable and ampere amplifier cable were exchanged, as well as exchanging the tactisys and generator which did not resolve the issue.A second catheter was obtained, but it could not be visualized despite signals being present.Additionally, it displayed a strange shape while in navx mode.A third catheter was then used to complete the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported event of an rf delivery issue was confirmed.The tip thermocouple displayed incorrect temperature readings during temperature testing and the temperature reading decreased with exposure to heat, consistent with the reported event.Further investigation revealed that the red and black tip thermocouple wires were soldered to the opposite pins in the 19-pin connector.The condition of the miswired tip thermocouple wires was determined to be consistent with a soldering issue during manufacturing.The root cause of the output issue was determined to be consistent with a manufacturing related issue.A corrective action was initiated to address this failure mode.

• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20693919
• Report Number: 3008452825-2024-00664
• Device Sequence Number: 20978477
• Product Code: OAE
• UDI-Device Identifier: 05415067034618
• UDI-Public: (01)05415067034618(10)10153983(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/24/2025

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: 12/31/2024
• Device Model Number: A-TFSE-FJ
• Device Catalogue Number: A-TFSE-FJ
• Device Lot Number: 10153983
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: TACTIFLEX¿ ABLATION CATHETER, SE
• Patient Sex: Unknown