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 Problem Optical Problem (3001)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

Related manufacturing ref: (b)(4).During a premature ventricular contraction procedure, the contact force measurement was not accurate which caused a delay in procedure.When using ensite precision, the contact force measurement was not accurate as the measured force at random was zero and 440 g, and then to 12 g, without movement of the catheter.Connections were checked and the tactisys module was replaced, which did not resolve the issue.The catheter was then exchanged, and the issue was resolved; however, the issue occurred again, with random force readings at 0 g to 18 g to 5 g (appropriate until contact force loss) and 410 g was displayed intermittently.The procedure was completed using intracardiac echo, with no patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported contact force issue and subsequent delay remain 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: 18344484
• MDR Text Key: 330720096
• Report Number: 3008452825-2023-00575
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• 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: 12/20/2023

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 Model Number: A-TCSE-DF
• Device Lot Number: 9213783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE.