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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacture ref: 3005334138-2025-00171.During an atrial tachycardia procedure, a positioning issue occurred and a fray was noted causing a procedure delay.It was found that the ablation catheter was not bent properly.Additionally, the tip of the puncture sheath was rough.The sheath and ablation catheter were replaced and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
Udi information (d4) and 510k (g3) are not provided within this report as this product (model: a-tcse-d) is an ous configuration not available in the us and is therefore not referenced in the gudid database.
Additional Manufacturer Narrative
One uni-directional, curve d, tacticath sensor enabled contact force ablation catheter was received for evaluation.The catheter did not meet deflection specifications when actuating the steering mechanism, consistent with the reported event.No visual anomalies were noted within the catheter handle.However, the deflection of the catheter was able to be brought back into specification by tightening the vectran suture around cam lock b, consistent with slack in the vectran suture and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the slack in the suture and subsequent delay remains unknown.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21712425
• Report Number: 3008452825-2025-00136
• Device Sequence Number: 11896989
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: (01)05415067027689(10)10333659(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/09/2025

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: 10/31/2025
• Device Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 10333659
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FAST-CATH¿ TRANSSEPTAL SWARTZ¿ SL.
• Patient Sex: Unknown