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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem 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x mapping system everything worked as expected.When the mapping was finished in the right atrium, the catheter was withdrawn into the inferior vena cava.The catheter was outside the sheath.After that, there was a red dot at the magnetic sensor indicator and the diagnostic catheters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.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h4, h11.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17908256
• Report Number: 2184149-2023-00206
• Device Sequence Number: 18009420
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: (01)05415067032171(21)18757612(10)7589671
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K231415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Was Device Available for Evaluation?: No
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 10/13/2023; 06/11/2024; 07/08/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/13/2023; 11/07/2023; 06/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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 Sex: Male