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	Use of Device Problem (1670); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: 2184149-2024-00160.During the supraventricular tachycardia procedure, communication issues resulted in a procedural delay.While using ensite x v3.0.1 in voxel mode, a tacticath se was connected to the ensite x amplifier with an se cable to se1 or se2 on the amplifier, and the system immediately displayed, "unexpected error" and the study was automatically closed.The amplifier, dws, and tactisys were all restarted but the issue was not resolved.The catheter was replaced but the issue persisted.The procedure was completed using the second catheter in navx mode and without connecting the se cable of the catheter to the amplifier, without magnetic navigation.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve f, tacticath sensor enabled contact force ablation catheter was received for evaluation.The magnetic sensor met specifications during electrical testing with no short circuits detected and the 10-pin connector eeprom met programming specifications.It was also determined that the catheter had a batch number 8972373 expired on 31aug2024 which was prior to the reported event date of 02 sep 2024.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event could not be attributed to this device.
Event or Problem Description
This report includes corrected device information and an updated medical device problem code.
Additional Manufacturer Narrative
Corrected information: b5, d4, g3, h2, h4, h6.

• 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: 20232611
• Report Number: 3008452825-2024-00522
• Device Sequence Number: 20961499
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: (01)05415067027696(10)9043126(17)241031
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 8972373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 11/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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
• Patient Sex: Unknown