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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a ventricular tachycardia ablation procedure, mitral valve insufficiency occurred.While in the left ventricle, a sudden drop in blood pressure was observed.An echocardiogram was performed which excluded pericardial effusion.A transesophageal echocardiogram was performed which revealed mitral valve insufficiency with an unknown cause.The procedure was stopped and the patient was transferred to the icu for continued monitoring.The ablation catheter was in the left ventricle when this issue occurred.The physician thinks the ablation performed during this procedure may have caused the valve to worsen, leading to dilation of the mitral ring.Mitral valve clips were placed and the patient continues to be monitored in the icu.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 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 catheter performed as intended.The optical fibers met specifications while inside the patient, 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.Due to unknown procedural conditions, we are unable to conclusively determine the cause of the reported event and the cause remains unknown.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21471930
• Report Number: 3008452825-2025-00083
• Device Sequence Number: 8821934
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: (01)05415067027696(10)10478901(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/06/2025

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: 01/31/2026
• Device Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 10478901
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 05/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown