MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TCSE-D
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the atrial fibrillation (pvi) procedure, a pericardial effusion was diagnosed which required a pericardiocentesis to stabilize the patient.During the procedure, with the catheter in the left atrium, the se point of the catheter was continuously displayed in red and the following error message was displayed: "catheter in port se1 has a magnetic sensor issue.Check connections and consider replacing the catheter or its cable." all connections were checked, with no resolution.No ablation had been performed yet.The catheter was exchanged which resolved the issue and the procedure continued.During the procedure, fluctuating blood pressure values (from 147/82 to 78/43 mmhg) were repeatedly noted, which were interpreted as a reaction to the anesthesia after ruling out a pericardial effusion via ultrasound.The heart anatomy was noted to be somewhat complicated, and some structures were not able to be correctly assigned on the model.The physician wanted to proceed with the ablation, despite the recommendation to continue collecting geometry data to get a better orientation.After performing the ablation, because the veins appeared to be signal isolated, the physician declared the examination complete.During the routine ultrasound at the end of the procedure, a pericardial effusion was observed.A pericardiocentesis was performed which removed 200ml of blood and the patient was transferred to the monitoring ward in a stable condition.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve d, tacticath sensor enabled contact force ablation catheter was received for evaluation.When the returned device was connected to the tactisys quartz unit, optical fibers 1-3 met specifications for optical properties and contact force was displayed with no error messages noted.The magnetic sensor, both thermocouples, and electrodes 1-4 met specifications during electrical testing with no open or short circuits detected.In addition, the device met specifications during temperature testing and flow rate testing.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.No anomalies were noted with the 10 pin eeprom payload, and the magnetic sensor was properly oriented.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D
• 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: 21506207
• Report Number: 3008452825-2025-00076
• Device Sequence Number: 20826693
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: (01)05415067027689(10)10585358(17)260331
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/31/2025

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: 03/31/2026
• Device Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 10585358
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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