MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-TFSE-D

Device Problem Overheating of Device (1437)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Related manufacturer report number: 3008452825-2023-00549.During an atrial fibrillation procedure, temperature increases were noted with the tactiflex ablation catheter inhibiting ablation, resulting in a delay.The issue persisted despite changing catheter orientation/anatomic location, removing the catheter, re-flushing, and power cycling the ampere generator.Additionally, the ampere generator, cool point pump, cool point pump tubing set, and tactisys quartz system were replaced, but with no resolution.The tactiflex ablation catheter was replaced for a second tactiflex ablation catheter but the same issue occurred again.The tactiflex ablation catheter was replaced again for a third tactiflex ablation catheter and the issue was resolved.The procedure was completed successfully with no adverse consequences to the patient.

Manufacturer Narrative

One uni-directional, curve d, tactiflex ablation catheter, sensor enabled was received for evaluation.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 device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Abbott is continuing to monitor this issue.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18291244
• MDR Text Key: 330127692
• Report Number: 3008452825-2023-00548
• Device Sequence Number: 1
• Product Code: OAE
• 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: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TFSE-D
• Device Lot Number: 9209357
• 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: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• 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¿