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 09/26/2023

Event Type  malfunction  

Event Description

Related manufacturing ref: 3005334138-2023-00469.During a voxel premature ventricular contraction procedure, a procedure delay occurred.The catheter was used to burn in the right ventricular outflow tract (rvot).While ablating, the catheter sensor indicator turned red and when hovering over it, it indicated a data quality error.The catheter would flash red and the force arrow would turn into a cone.There were no prss errors on the mapping catheter.The ablation catheter was confirmed to be outside the sheath and the sheath filter was reset, but the issue persisted.The se connection port was tried with and without the extension cable, but the issue continued.Impedance and other rf parameters worked as expected.No catheter preset was used and the catheter auto-detected when plugged in.The catheter was exchanged for a second device, however, the second catheter reached 40 degrees celsius repeatedly despite being in an area of normal blood flow and impedance.Tempguard was left on and power automatically titrated down to 15w despite being set at 40w.Default irrigation was used with the coolpoint pump.A third catheter was used which resolved the issue and the procedure was completed with no consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.A simulated ablation was performed and no temperature or power delivery anomalies were noted.The catheter met specifications during electrical testing and irrigation flow testing.Further inspection of the distal electrode indicated the tip thermocouple was inadequately bonded within the distal tip well, consistent with the reported event.The cause for the reported overheating and subsequent delay were due to an electrical problem.

• 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17930576
• MDR Text Key: 325608225
• Report Number: 3005334138-2023-00470
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8981114
• 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: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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
• Treatment: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿