MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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	Fracture (1260); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Optical fiber 3 did not meet specifications for optical properties and no contact force was displayed when the catheter was connected to the tactisys quartz unit.Further investigation revealed the shaft had been fractured in multiple locations and optical fiber 3 was fractured at the location of one of the shaft fractures, consistent with the detected optical signal issue and the reported issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured optical fiber remains unknown.
Event or Problem Description
This report is to advise of a fracture found in the catheter during analysis exposing internal wiring.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Investigation revealed the shaft had been fractured between electrode rings 2 and 3 as well as proximal to electrode ring 4.A braid was protruding from the fractured shaft proximal to e4.Optical fiber 3 was fractured at the location of the shaft fracture proximal to electrode ring 4, consistent with the detected optical signal issue and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shaft fracture proximal to electrode ring 4 remains unknown.A capa exists related to the fracture in the shaft material.The root cause of this device deficiency was determined to be damage to the catheter tip during removal of the catheter from its packaging due to the design of the tip protector.

• 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, COSTA RICA LTDA; 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; 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: 20761630
• Report Number: 3008452825-2024-00685
• Device Sequence Number: 8422748
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: (01)05415067027634(10)10155868(17)250630
• 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): 09/30/2025

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: 06/30/2025
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 10155868
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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
• Patient Sex: Unknown