MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TFSE-D
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: 3005334138-2024-00372.During a premature ventricular contractions procedure, optical issues with the catheter resulted in a procedural delay.While at the vascular access step, it was noted that the ablation catheter would not display pressure information on the ensite x dws, an error message showed, -- g contact force data in purple was displayed.The catheter was reconnected multiple times, the tactisys was restarted, the catheter preset was reloaded and the study was restarted, all with no resolution.The same issue occurred with the second catheter.The catheter was exchanged for a third which resolved the issue and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve d, tactiflex ablation catheter, sensor enabled was received for evaluation.When the returned device was connected to the tactisys quartz unit, optical fibers 1-3 no longer met specifications for optical properties and no contact force was displayed.Further investigation revealed optical fibers 1-3 intermittently met specifications for optical properties when force was applied to the distal tip, consistent with a deformation of the tip assembly and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deformation of the tip assembly remains unknown.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20190290
• Report Number: 3005334138-2024-00373
• Device Sequence Number: 8138532
• Product Code: OAE
• UDI-Device Identifier: 05415067034656
• UDI-Public: (01)05415067034656(10)10374423(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P220013
• 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): 11/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: A-TFSE-D
• Device Catalogue Number: A-TFSE-D
• Device Lot Number: 10374423
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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