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 Problems Display or Visual Feedback Problem (1184); Overheating of Device (1437); Communication or Transmission Problem (2896)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Related manufacturing ref: 3008452825-2022-00665.During the atrial fibrillation ablation procedure, there was a communication issue with 2 tactiflex catheters resulting in delay of procedure.When using the ensite x in voxel mode, after the puncture, the left atrium was approached with the ablation catheter and the ring, and map was obtained under cs pace.After that, when it was attempted to execute eepvi, the temperature control was applied from the first point, and the output became 18 watts on average.The issue was with the temperature sensor abnormality.After that, there was also an issue with the arrow, so the system reference patch and catheter were exchanged but the issue did not resolve.When flushed and inserted into the body, the catheter was displayed on the ensite x, but it was not recognized on the ampere generator, and the message "no catheter is connected" continued to display.The ampere generator and the tactisys were power cycled and exchanged, the cable between tactisys-ampere generator was exchanged, the ensite x was power cycled, the system reference was exchanged, but the ampere generator still did not recognize the catheter.The catheter was exchanged again and the issue resolved.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.When connected to the tactisys quartz unit, the device met specifications for optical signal properties.In addition, the device met specifications during temperature testing and electrical testing with no open or short circuits detected.The calibration data stored on the device eeprom was determined to be incorrect due to a force calibration issue, consistent with force inaccuracy and the reported contact force arrow issue.A simulated ablation was performed, and the catheter displayed a high average temperature rise, consistent with the reported event.The catheter met specifications during electrical testing and irrigation flow testing.The cause for the reported communication issue and subsequent delay were unable to be conclusively determined.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported temperature control, power cutoff, and contact force arrow issues were confirmed.When connected to the tactisys quartz unit, the device met specifications for optical signal properties.In addition, the device met specifications during temperature testing and electrical testing with no open or short circuits detected.The calibration data stored on the device eeprom was determined to be incorrect due to a force calibration issue, consistent with force inaccuracy and the reported contact force arrow issue.A simulated ablation was performed, and the catheter displayed a high average temperature rise, consistent with the reported event.The catheter met specifications during electrical testing and irrigation flow testing.Abbott is continuing to monitor the detected force calibration issue.The root cause of the reported temperature control and power cutoff issue will continue to be monitored.

• 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: 15763335
• MDR Text Key: 307742778
• Report Number: 3008452825-2022-00664
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P220013
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8623258
• 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: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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
• Treatment: TACTIFLEX¿ ABLATION CATHETER SE.