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-DF

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, temperature display issues and uneven generator waveforms resulted in the inability for pulmonary vein isolation to be performed and the procedure was cancelled.The catheter was inserted into the heart chamber and connected to the tactisys.Attempts were made to perform rf delivery for pulmonary vein isolation, but neither the right pulmonary vein nor the left pulmonary vein were able to isolate.No error message was displayed but it was noted that the temperature display during rf delivery was uneven with generator waveforms on ensite.The procedure was cancelled without replacing the catheter and without completing the pulmonary vein isolation.There were no adverse consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.One image was returned to product performance engineering.The photo appears to show noisy generator waveforms and temperature readings during rf delivery, consistent with the reported event.The catheter met specifications during electrical testing with no open or short circuits detected.In addition, the catheter met specifications during occlusion, leak, and irrigation flow rate testing.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 overheating of the device and subsequent cancellation remains unknown.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: 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: 16497006
• MDR Text Key: 310817010
• Report Number: 3008452825-2023-00053
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8708428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1