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	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, there was a temperature issue resulting in cancellation of the procedure.While ablating in the rvot 2, the earliest activation at infundibulum, the temperature alarm sounded.The tip orientation during ablation was at a slight angle, but rather perpendicular.When a second ablation was performed, the following error message was displayed on the ampere: "power not possible".Troubleshooting was done by restarting and reconnecting the catheter and the first attempted ablation error was as following: "measured power higher than programmed value".The decision was made to end the procedure and not exchange the catheter due to time constraints and the need to reinduce the pvcs.There were no adverse patient health consequences.
Additional Manufacturer Narrative
One bi-directional, curve d-d, tactiflex ablation catheter, sensor enabled was received for evaluation.Two images were submitted for analysis which showed a ¿measured power higher than programmed limit¿ error message on the ampere generator, consistent with the reported event.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.The cause of the power delivery and unexpected temperature control issue 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19925333
• Report Number: 3008452825-2024-00426
• Device Sequence Number: 8083098
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: (01)05415067034557(10)10162247(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/27/2024

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: 12/31/2024
• Device Model Number: A-TFSE-DD
• Device Catalogue Number: A-TFSE-DD
• Device Lot Number: 10162247
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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
• Patient Age: 26 YR
• Patient Sex: Unknown