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

Model Number	A-TFSE-F
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia procedure, a communication issue occurred resulting in cancellation of the procedure.The catheter was intermittently seen on the ensite x in voxel mode around the low septal apex area of the right ventricle and left ventricle.There was also an icd lead in the septal area.Prs and distortion levels were within range and the catheter kept disappearing, even during ablation.After some ablations, the catheter was still visible on the ensite x system, but the generator indicated a "catheter not connected" message.Signals were still able to be seen, but ablation parameters were not functional.The procedure was then cancelled with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One uni-directional, curve f, tactiflex ablation catheter, sensor enabled 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.No anomalies were noted on the eeprom payloads.Electrode 1, deformable body thermocouple, and the magnetic sensors met specifications during electrical testing with no open or short circuits detected.The tip thermocouple displayed an open circuit, consistent with the reported event.The open circuit was isolated to the green catheter shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported error message and subsequent cancellation may have been due to the open circuit.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22478150
• Report Number: 3005334138-2025-00428
• Device Sequence Number: 15564567
• Product Code: OAE
• UDI-Device Identifier: 05415067034670
• UDI-Public: (01)05415067034670(10)10684739(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 08/12/2025

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: 12/31/2025
• Device Model Number: A-TFSE-F
• Device Catalogue Number: A-TFSE-F
• Device Lot Number: 10684739
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown