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

Model Number	A-TCSE-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the procedure, a blood clot was noted on the tip of the catheter.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
One uni-directional, curve j, tacticath sensor enabled contact force ablation catheter was received for evaluation.A blood-like substance was noted at the distal tip of the catheter.The device met specifications during temperature testing, occlusion testing, and leak testing.In addition, electrode 1 and the tip thermocouple met specifications during electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported blood clot remains unknown.
Event or Problem Description
Following the procedure, a blood clot was noted on the tip of the catheter.There were no adverse consequences for the patient.The baseline impedance was around 100 ohms prior to ablation.Heparin as anticoagulation therapy.The catheter was in smooth tissue in the left atrium but probably in trabeculated tissue in the mitral and the cavo-tricuspid isthmus.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE J
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14718016
• Report Number: 3008452825-2022-00480
• Device Sequence Number: 2235340
• Product Code: OAE
• UDI-Device Identifier: 05415067027702
• UDI-Public: 05415067027702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/22/2022

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: 04/30/2023
• Device Model Number: A-TCSE-J
• Device Catalogue Number: A-TCSE-J
• Device Lot Number: 8228005
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: Other
• Patient Sex: Unknown