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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular tachycardia (pvc) ablation procedure in the voxel mode, a communication issue occurred causing a delay.The tactisys was powered on and physically connected to the catheter and amplifier, but was not recognized by the ensite x system, and did not display contact force.All connections were double checked and restarted, the tactisys to ampere ethernet cord was replaced, and the tactisys serial number was deleted and reentered into ensite x.Despite those steps, the tactisys would not connect.A different tactisys from another lab in the hospital used to and immediately connected and functioned properly.The case was successfully completed with no patient consequences.
Additional Manufacturer Narrative
Additional information: a2, a4, 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 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 tactisys was functioning as intended during investigation.The logs of the tactisys quartz were not available to review.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 of the reported communication issue and subsequent delay could not be conclusively determined.

• 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: 20891858
• Report Number: 2184149-2024-00211
• Device Sequence Number: 15630759
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)7550326
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/28/2025

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
• Device Model Number: PN-004 400
• Device Catalogue Number: PN-004 400
• Device Lot Number: 7550326
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2016
• 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: 61 YR
• Patient Sex: Unknown
• Patient Weight: 74 KG