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 Codes	Communication or Transmission Problem (2896); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a right atrial flutter procedure, an error message occurred causing a procedure delay.The catheter was connected to the generator with an impedance reading of approximately 100 ohms, and an error message was noted stating: "catheter not connected".This error appeared with two different ampere generators.The catheter was exchanged which did not resolve the issue.The tactiflex catheter was replaced with a tacticath se but the issue was not resolved.The ensite x was then switched to ensite precision, which resolved the issue with no consequences to the patient.It should be noted that the ensite x has been used since with no issues noted.
Additional Manufacturer Narrative
One bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported ¿catheter not connected¿ error and impedance issue could not be confirmed.No anomalies were noted on the eeprom payloads.The tip thermocouple and tip electrode met specifications during electrical testing with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Additional Manufacturer Narrative
One bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported ¿catheter not connected¿ error on the ampere issue was confirmed.No anomalies were noted on the eeprom payloads.The tip thermocouple and tip electrode met specifications during electrical testing with no open or short circuits detected.The tip thermocouple displayed incorrect temperature readings during temperature testing and the temperature reading decreased with exposure to heat.Further investigation revealed that the red and black tip thermocouple wires were soldered to the opposite pins in the 19-pin connector, consistent with the reported event.The condition of the miswired tip thermocouple wires was determined to be consistent with a soldering issue during manufacturing.

• 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: 19124339
• Report Number: 3008452825-2024-00216
• Device Sequence Number: 18049581
• Product Code: OAE
• UDI-Device Identifier: 05415067034618
• UDI-Public: (01)05415067034618(10)10133623(17)241130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2024

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: 11/30/2024
• Device Model Number: A-TFSE-FJ
• Device Lot Number: 10133623
• Was Device Available for Evaluation?: Yes
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 04/30/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 04/25/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED.
• Patient Sex: Unknown