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

Model Number	A-TCSE-DD
Medical Device Problem Codes	Overheating of Device (1437); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: (b)(4).During a supraventricular tachycardia procedure, an optical issue occurred causing a delay in procedure.The catheter was connected to the tactisys, but the pressure did not display normally, indicating that the catheter was not connected.The tactisys module and radio frequency instrument were restarted, and the catheter was reseated with no resolution.The catheter was then replaced and the pressure showed normally.However, during the procedure, the temperature was not as expected and during ablation, the temperature was 39-40 degrees celsius.During ablation, the pressure gradually increased with the radiofrequency ablation time.The catheter was replaced again and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-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.Electrode 1 and both thermocouples met specifications during electrical testing with no open or short circuits detected.In addition, the catheter met specifications during leak and occlusion testing as well as temperature accuracy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Udi information (d4) and 510k (g3) are not provided within this report as this product (model a-tcse-df) is an ous configuration not available in the us and is therefore not referenced in the gudid database.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-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, COSTA RICA LTDA (AFD); 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: 20271620
• Report Number: 3008452825-2024-00543
• Device Sequence Number: 19715654
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: (01)05415067027634(10)10318595(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: No
• Device Expiration Date: 09/30/2025
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 10318595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown