MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the svt procedure, an optical problem occurred causing a procedure delay.It was noted the contact force values were not able to be seen.Exchanging the catheter did not resolve the issue.The tactisys was exchanged and the procedure was successfully completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
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, post (power-on-self-test) was completed, and communication was established.A known-good catheter was connected and contact force was not observed.Fiso diagnostic revealed a signal loss at channel two.Inspection of the lc/lc fiber optic adapter revealed no light on slot 2.The tactisys was opened, and internal visual inspection revealed all mounting hardware were secured.The fiso module at channel two was temporarily replaced with a known-good one which channel two appeared to be functional and contact force was observed.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 and investigation provided to abbott, the root cause was isolated to the fiso module in channel two.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Common Device Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21969599
• Report Number: 2184149-2025-00086
• Device Sequence Number: 8160685
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)8476238
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 05/06/2025

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: 8476238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown