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-DD
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a steam pop and cardiac perforation occurred requiring a pericardiocentesis.It was noted that a pop occurred in the right atrial anterior.Electrical conduction was initiated from the posterior side of the right pulmonary vein roof, and a pop occurred when passing the bottom and reached the anterior side.After the pop was confirmed, a pericardiocentesis was performed for treatment.The procedure was completed without replacing the device.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-d, tactiflex ablation catheter, sensor enabled was received for evaluation.When the returned device was connected to the tactisys quartz unit, optical fibers 1-3 met specifications for optical properties and contact force was displayed with no error messages noted.The magnetic sensors, both thermocouples, and electrode 1 met specifications during electrical testing with no short circuits detected.In addition, the device met specifications during temperature testing and flow rate testing.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.The event description states that rf energy was applied at 50w for approximately 17 seconds.Tactiflex ablation catheter, sensor enabled instructions for use (ifu) recommends using a power of 50w for up to 10 seconds and warns ¿application of rf energy outside of the power and duration recommendations may increase the likelihood of steam pop occurrence.¿ however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event and the cause remains unknown the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported steam pop and cardiac perforation could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20333122
• Report Number: 3008452825-2024-00566
• Device Sequence Number: 18539812
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: (01)05415067034557(10)10334695(17)250430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: A-TFSE-DD
• Device Catalogue Number: A-TFSE-DD
• Device Lot Number: 10334695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown