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 Signal Artifact/Noise (1036)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

During the atrial fibrillation/atrial tachycardia procedure, noise issues resulted in a procedural delay.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.There was no problem with the electric potential when the catheter was inserted into the heart and connected to the tactisys and ensite, but after mapping, noise was noted on abl1-2 when rf delivery was started.The input box of the recording system was reconnected, the catheter was reconnected to the tactisys and ensite, the ensite and recording system were restarted, and it was re-grounded, with no resolution.The catheter was replaced which resolved the issue and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 one bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.Electrode 2 read as an open circuit during electrical testing.Further investigation revealed that conductor wire 2 was fractured proximal to the weld joint between the wire and the electrode ring, consistent with the detected open circuit, and the reported event.In addition, electrode 1 met specifications during electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of fractured conductor wire 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: 18337540
• MDR Text Key: 330832194
• Report Number: 3008452825-2023-00572
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TFSE-DF
• Device Lot Number: 9233626
• 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: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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