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	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, there was no contact force from the tactiflex catheter.The catheters and cables were exchanged and multiple reboots were done.Additionally, the fiber port was cleaned with no resolution and the case was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One tactisys quartz was received for evaluation.Visual inspection revealed the front ports, rear ports, enclosure, and label were free of physical damage.When power was applied, the tactisys completed post (power-on-self-test) and communication was established.A known-good catheter was connected, and contact force was observed.Fiso diagnostic revealed all three channels were functional.The tactisys was left on for an extended period with no anomalies observed.Inspection of the logs revealed a ¿no force information available¿ message on the reported event date.The catheter logs also show that there was no force available however the root cause could not be conclusively determined as the returned tactisys was functioning as intended.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.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event could not be conclusively determined as the tactisys functioned as expected throughout the investigation.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23006632
• Report Number: 2184149-2025-00149
• Device Sequence Number: 10559448
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)10626561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 10626561
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White