MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X DWS V5.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-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	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a radiofrequency ablation ventricular tachycardia procedure, there was a procedural delay.The catheter displayed correctly, but when attempting to save an ice image using ensite echo, the ensite dws froze.The viewmate multi, ensite dws, and ensite x amplifier were restarted multiple times with no resolution.The dws and catheter were replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
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 were attempted.The issue was not replicated.The root cause could not be conclusively determined due to the exact behavior not being replicable.

• Brand Name: ENSITE X DWS V5.0.1
• 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: 24576501
• Report Number: 2184149-2026-00065
• Device Sequence Number: 16071063
• Product Code: DQK
• UDI-Device Identifier: 05415067053510
• UDI-Public: (01)05415067053510(10)11192869
• 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): 04/27/2026

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-DWS-05
• Device Catalogue Number: ENSITE-DWS-05
• Device Lot Number: 11192869
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIEWFLEX¿ X ICE CATHETER SENSOR ENABLED¿.
• Patient Sex: Unknown