MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X V5.0 SOFTWARE UPGRADE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-05
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia and pulsed field ablation pulmonary vein isolation procedure, there was a delay due to ensite x freeze issues.The ensite x froze when attempting to save and make ice contour with the ensite echo module.While automapping with the advisor hd grid x catheter in voxel mode, the ensite froze.The computer was restarted and the case was reloaded, but the ensite froze again once loaded.The computer was restarted again and a new case was started for the existing patient, which loaded a freeze again.Everything was disconnected, the dws, ensite amplifier, and current generator were restarted in that order, and a brand new case was able to be started.The procedure was completed without ensite echo.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite¿ x dws was received for evaluation.The reported event stated that "the dws launched integrated ice, and the dws would freeze when ice image contours were selected and saved." the case study and log files were reviewed.Attempts to replicate the freeze using the returned device were also attempted.The exact issue was not replicated.It was observed that the dws screen became black for several minutes and required a shutdown.Lag between the viewmate multi (vmm) and ensite ice image could be reproduced.There were also issues with time sync between the vmm and the ensite system.The root cause could not be conclusively determined due to the exact behavior not being replicable.The batch 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¿ X V5.0 SOFTWARE UPGRADE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24586655
• Report Number: 2184149-2026-00064
• Device Sequence Number: 15762989
• Product Code: DQK
• UDI-Device Identifier: 05415067053435
• UDI-Public: 05415067053435
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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-SW-05
• Device Catalogue Number: ENSITE-SW-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown