MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X DWS V4.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-04
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular nodal reentrant tachycardia procedure there was a delay.The procedure was started with ensitex dws 9 (v5.0.1) and his, cr, and hra catheters were inserted in the patient.All the catheters appeared elongated and stacked on each other.Though the egms and surface signals were fine.The system was rebooted with no resolution.A new case was started but an amplifier issue occurred and tech support was called.Everything had to be disconnected from the amplifier to get it to boot up correctly.After that, there were several impedance errors and geography could not be collected.The catheters were unable to show or were distorted.The navx patches were replaced with no resolution.A tactiflex catheter was used but the same issue occurred with the catheter appearing distorted in navx.In voxel mode, the se gumball kept having "invalid shaft electrode data" and "poor impedance data" errors.Shadows were dropped, and the force arrow was working as expected but could not collect data.The procedure was completed with using fluoroscopy and signals.Further troubleshooting at a later date determined that the issue was the dws which has been since replaced.
Additional Manufacturer Narrative
One ensite x display workstation (dws9) z4 was received for evaluation.The reported event was not able to be duplicated.Hardware evaluation testing was successful.Based on the investigation, and information provided to abbott, the reported event was not able to be confirmed, and the root cause remains undetermined.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 DWS V4.0
• 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: 24315139
• Report Number: 2184149-2026-00036
• Device Sequence Number: 4837702
• Product Code: DQK
• UDI-Device Identifier: 05415067051257
• UDI-Public: (01)05415067051257(10)10961266
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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-04
• Device Catalogue Number: ENSITE-DWS-04
• Device Lot Number: 10961266
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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
• Patient Sex: Unknown