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 Code	Perforation of Esophagus (2399)
Type of Reportable Event	Death
Event or Problem Description
It is reported that 3 weeks following a persistent atrial fibrillation ablation procedure, the patient developed an atrioesophageal fistula and died.During the procedure, which was done after a former pulmonary vein isolation procedure, the physician reports a difficult transseptal puncture during the procedure.A pericardial effusion was suspected so the transesophageal echocardiogram (tee) probe was used throughout the procedure to continually monitor for an effusion.The pulmonary veins were isolated and the physician decided to make an isolation of the posterior box and an anterior mitral line from the mitral annulus to the right pulmonary superior vein.It was not possible to use the esophageal temperature monitoring probe because of the presence of the tee probe during the entire procedure.The procedure was completed with no effusion being detected.A thoracic scan was performed later that day which was also negative for any effusion.Three weeks post-procedure, the patient was admitted to the emergency room for bloody vomiting and fever.A gastroscopy was requested without using air insufflations but co2.The gastroscopy showed a perforation in the esophagus that could be done with the tee probe.A thoracic scan was also performed and was reassuring.The patient was admitted to the icu.Another scan and gastroscopy were done and both were reassuring.The next day, another gastroscopy was ordered but was done with air inflating because the former gastroscopy showed an esophageal perforation.Later that day, a new thoracic scan was ordered and showed a large amount of air in the brain.It is now believed that a fistula was created between the left atrium and the esophagus during the procedure done on (b)(6) 2024.There were no reported performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, the ensite automark files were returned.Analysis of the files indicated no power, temperature, or impedance anomalies during the recorded rf sessions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18977629
• Report Number: 3008452825-2024-00159
• Device Sequence Number: 17651090
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: (01)05415067027696(10)9242432(17)250228
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 9242432
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 08/04/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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: Death
• Patient Sex: Unknown