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	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation / atrial flutter procedure, optical and impedance issues occurred, and the procedure was cancelled.It was reported that the contact force values would intermittently go in and out.The catheter was replaced which seemed to resolve the issue, but then contact force values appeared incorrect.It was also reported that the impedance value on the ampere generator was displayed as 999.A third catheter was introduced, and the tactiflex rf cable was replaced, but the issue persisted, and the procedure was abandoned.It was unknown as to whether the tactisys or the ampere generator caused the issue.
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, the tactisys completed the 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 reported symptom was unable to be duplicated as contact force was tested, and no anomalies observed.The tactisys was functioning as intended during investigation.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 remains undetermined.

• 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: 22078090
• Report Number: 2184149-2025-00099
• Device Sequence Number: 21010448
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)10523074
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/19/2025

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: 10523074
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPERE GENERATOR.
• Patient Sex: Unknown