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

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

During an atrioventricular nodal reentrant procedure, an optical issue occurred causing a procedure delay.After the insertion of ablation catheter, the distal electrode was visualized as elongated and did not show signals on the bipole.After checking the connection between the tactisys, ampere and ensite precision, it was decided to exchange the catheter for another of the same type which did not resolve the issue.After that, it was suspected that the issue was due to the tactisys.An attempt to use another ablation catheter had the same problem.The procedure was completed by the classical method with no consequences to the patient.

Manufacturer Narrative

D1, d4, d9, g3, h2, h3, h4 one ampere generator was received for analysis with no accessories available for inspection.Visual inspection found all labeling and input/output connectors to be free of physical damage.The device was plugged in and powered on successfully.A load box was connected to the unit and the measured impedances were found to be normal.A catheter connection was simulated, and the unit connected without issue.Test ablations were performed, and the unit functioned normally.The log files on the unit were reviewed and were unable to conclusively confirm the reported event.The reported complaint was unable to be confirmed.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 received and the investigation performed, the returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.The cause for the reported optical issue and subsequent delay remains unknown.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18402206
• MDR Text Key: 331605371
• Report Number: 2184149-2023-00257
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-004 400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1