MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-DF

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Overheating of Device (1437); Patient Device Interaction Problem (4001)

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

Event Date 02/09/2022

Event Type  malfunction  

Event Description

During the persistent atrial fibrillation procedure, noise occurred during rf delivery, and when rf delivery was started on the front side of the right pulmonary vein, the temperature increased to 43 degrees celsius and at the same time, the impedance also increased from approximately 100 ohms to 160 ohms.The catheter was removed from the patient and thrombus was confirmed to had adhered to the tip of the catheter and the inside of the sheath.The rf delivery site was not an uneven structure.The thrombus was wiped off and rf delivery was attempted to be delivered again, however, noise occurred again.When the catheter was removed from the patient, char was noted at the tip of the catheter.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.The preoperative examination showed no indication of possible thrombosis or underlying disease.

Manufacturer Narrative

One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Two images were also submitted to product performance engineering for evaluation.The reported event of char and thrombus was confirmed.The first image submitted with the returned device appears to show noise on the egm of the 1-2 ablation bipole.The second image submitted with the returned device appears to show a charred blood-like substance on a piece of gauze, consistent with the reported thrombus and char; however, no char or blood-like substances were noted at the distal tip of the returned device.The device met specifications during temperature testing, occlusion testing, and leak testing.In addition, electrodes 1-4 and the tip thermocouple met specifications during electrical testing.A simulated ablation test was conducted, and no noise was present during ablation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported char / thrombus remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• 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: 13711852
• MDR Text Key: 286868730
• Report Number: 3008452825-2022-00093
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130026
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 8106630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• 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