MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-DWS-01

Device Problem Output Problem (3005)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

During an atrial tachycardia procedure, an output problem occurred causing a procedure delay.An issue was noted with the advisor hd grid catheter when using ensite x (v2.0.1) in voxel mode.After connecting the catheter to the ensite x mapping system everything worked as expected.When the mapping was finished in the right atrium, the catheter was withdrawn into the inferior vena cava.The catheter was outside the sheath.After that, there was a red dot at the magnetic sensor indicator and the diagnostic catheters were not visible.The prs sensors were correctly shown in green color, with no distortion.The catheter was returned to the right atrium, and signals were seen from all the catheter electrodes but still a red dot at the magnetic sensor indicator.The catheter cable was replaced with no resolution.The amplifier was rebooted, the position of magnetic frame was moved a bit, and the dws was rebooted but the issue did not resolve.When the study was resumed, there was an error on the dws ¿an active enguide is required to resume a study¿.The catheter was replaced but the issue remained.A new study was started with the new catheter and the case was completed with no patient consequences.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 17908256
• MDR Text Key: 325317119
• Report Number: 2184149-2023-00206
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K231415
• 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,Followup
• Report Date: 11/07/2023

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: ENSITE-DWS-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 10/13/2023
• Supplement Dates FDA Received: 10/13/2023; 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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
• Patient Sex: Male