MAUDE Adverse Event Report: ABBOTT MEDICAL TACTISYS¿ QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	PN-004 400
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, it was noted that the tactisys quartz could not be brought to zero, and the contact force was not displayed on the screen (remained purple).The procedure was cancelled.There were no adverse consequences to the patient as a result of the cancellation.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One tactisys quartz sn (b)(6) was received for evaluation.When power was applied, the tactisys was unable to be connected and contact force data will not be available in a disconnected state.The tactisys was connected to remote desktop and the text file revealed a "fiso calibration expired".The reported event was confirmed by logs review and the root cause was isolated to fiso expired calibration.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22202540
• Report Number: 2184149-2025-00116
• Device Sequence Number: 12451505
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)5898984
• 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): 08/21/2025

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 Model Number: PN-004 400
• Device Catalogue Number: PN-004 400
• Device Lot Number: 5898984
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• 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