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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pvc procedure, optical issues with the tactisys resulted in a procedural delay.The ablation catheter was inserted into the heart chamber and connected to the tactisys and ensite, however the contact force value was not displayed on the ensite.The tactiflex catheter was reconnected to the tactisys, and the tactisys, ensite amplifier, and ensite dws were all restarted, but the issue persisted.The catheter was replaced but the issue was not resolved.The procedure was completed without replacing the tactisys and without contact force being displayed and with no adverse consequences to the patient.After the procedure, the issue was resolved by replacing the tactisys.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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: 22642339
• Report Number: 2184149-2025-00135
• Device Sequence Number: 8823149
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)8690439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/22/2025

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: 8690439
• Was Device Available for Evaluation?: No
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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