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 Failure to Power Up (1476)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

During a premature ventricular contraction procedure, the tactisys did not power on and the procedure was cancelled.After mapping was completed, when beginning ablation, the tactisys unit did not power on.The power cord connection to the system was exchanged, the power cord and all other cords were unplugged and then plugged back in which did not resolve the issue and the procedure was cancelled with no ablation completed.

Manufacturer Narrative

One tactisys¿ quartz was received for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.The quartz was powered on and audible beeps were observed.This indicates the quartz successfully booted and communication was established.A known-good catheter was connected, and valid contact force was observed.A fiso diagnostic verified all fiso compact module signals were within specifications.The field reported event was not reproduced as the quartz was left-on for an extended period and no anomaly was observed.Communication and valid contact force were maintained.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 reported failure to power up and subsequent cancellation could not be conclusively determined as the returned tactisys functioned as anticipated throughout the investigation.

• 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: 18343814
• MDR Text Key: 330714808
• Report Number: 2184149-2023-00247
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: 07640157990194
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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 Operator: Health Professional
• Device Model Number: PN-004 400
• Device Lot Number: 6979766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2019
• 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