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

Model Number	A-TCSE-F
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrioventricular reentrant tachycardia procedure, the left ventricle ruptured causing a cardiac tamponade requiring a sternotomy to control the bleeding.The catheter was introduced through the aorta and the tacticath catheter was positioned in the lateral isthmus with an average of 60-70 grams of force.The physician was advised that the catheter had too many grams of force, but it was alleged that the force was higher than what was actually occurring.After 1 second of rf, the tachycardia stopped but ablation was continued for a minute and a half reaching an lsi of 11.2.Right after the patient started feeling dizzy and with a heavy pressure on their chest.An echocardiogram confirmed the left ventricle was ruptured with the ablation catheter and a cardiac tamponade developed.An emergency sternotomy was performed to control the bleeding.During reparative surgery, a hole was found on the ventricular aspect of the mitral valve.It was repaired and the patient is at the icu recovering.There were no alleged issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported cardiac tamponade remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE F
• 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: 22019516
• Report Number: 3008452825-2025-00221
• Device Sequence Number: 8804915
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: (01)05415067027696(10)10481485(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P130026
• 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): 06/23/2025

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 Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 10481485
• Was Device Available for Evaluation?: No
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 41 YR
• Patient Sex: Female