MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ SYSTEM DWS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100129557

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

During a hybrid atrial fibrillation procedure, there was an optical issue with the tactisys quartz system, and a communication issue with the ensite precision display workstation, resulting in cancellation of the procedure.When setting up the ensite precision mapping system, there was no contact force on the tactisys quartz system.The system was already validated with a tacticath ablation catheter, but it was noted there was no connection with the tactisys quartz system.It was noted that the tactisys quartz system status light was red.The tactisys quartz system was restarted multiple times, but the issue did not resolve.It was confirmed that the correct serial number was set up with the case.Another tactisys quartz system was then set up with the same serial number.The tactisys quartz system was started up normally, but there was no connection to the ensite precision mapping system.The utp cables were exchanged, and the tactisys quartz system was directly connected to the data port of the ensite precision mapping system with no resolve.The procedure was then stopped.Later the second tactisys quartz system was able to be successfully connected to the ensite precision mapping system.The issue after exchanging the first tactisys quartz system was isolated to an ensite precision system network connection error.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.

• Brand Name: ENSITE VELOCITY¿ SYSTEM DWS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19183617
• MDR Text Key: 341361055
• Report Number: 2184149-2024-00081
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K201181
• 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: 05/15/2024

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: 100129557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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