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

Model Number A-TCSE-FJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/06/2023

Event Type  Injury  

Event Description

During a left premature ventricular contractions ablation procedure, a pericardial effusion occurred which required a pericardiocentesis to stabilize the patient.During ablation, high co2 level and hypotension were noted.The procedure was stopped and an echocardiogram was performed which confirmed an effusion, the perforation was located at mid-anterior side of the left ventricle.A pericardiocentesis was done to stabilize the patient.There were no reported performance issues with any abbott device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.Due to unknown procedural conditions, we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
• 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: 18325036
• MDR Text Key: 330486418
• Report Number: 3008452825-2023-00565
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027665
• UDI-Public: 05415067027665
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TCSE-FJ
• Device Lot Number: 9253689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening