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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
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, the left pulmonary vein isolation was completed, and when moving to the right pulmonary vein, the patient became hypotensive.An echography revealed a cardiac tamponade which required a pericardiocentesis to stabilize the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.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.Due to unknown procedural conditions, we are unable to conclusively determine the cause of the reported event.The cause of the reported perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
Additional Manufacturer Narrative
Correction: h6 code: medical device problem code.

• 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: 20272318
• Report Number: 3008452825-2024-00546
• Device Sequence Number: 7240964
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: (01)05415067034557(10)10337726(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,Followup
• Report Date (Section B): 11/05/2024

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: 04/30/2025
• Device Model Number: A-TFSE-DD
• Device Catalogue Number: A-TFSE-DD
• Device Lot Number: 10337726
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/04/2024; Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/04/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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