MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE F; ELECTRODE RECORDING CATHETER

Model Number	A-TCSE-F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a pericardial effusion occurred requiring a pericardiocentesis.After left pulmonary vein isolation the patient became hypotensive.An echocardiography confirmed a pericardial effusion around the right and left heart cavities.The procedure was stopped, and the pericardial effusion was drained by percutaneous puncture, which stabilized the patient.It is unknown what caused this pericardial effusion.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.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: ELECTRODE RECORDING CATHETER
• 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: 18547465
• Report Number: 3005334138-2024-00008
• Device Sequence Number: 20417056
• Product Code: OAE
• UDI-Device Identifier: 05415067024800
• UDI-Public: 05415067024800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/20/2024
• 2 Devices were Involved in the Event: 1 2

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 Lot Number: 9059570
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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