MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X EP SYSTEM V3.1.1; Computer, diagnostic, programmable

Model Number	ENSITE-SW-3.1.1
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event stated that "the catheter electrode navigation display remained grayed - preventing map acquisition" and "when the mode was switched from voxel to navx, the catheter navigation display appeared to have collapsed and could not be displayed properly.¿ the results of the investigation are inconclusive since the device was not returned for analysis.Device logs and/or case studies were requested but were not available for review.As the manufacturing process does not impact the performance of the software, a review of the device history record (dhr) was not performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During a pulsed field ablation procedure, there was a delay due to a graphical user interface issue.When using the ensite x system (v3.1.1) in voxel mode, the voxel point acquisition and geometry acquisition were possible.Despite acquiring multiple voxel points, the catheter electrode navigation display remained grayed - preventing map acquisition.When the mode was switched from voxel to navx, the catheter navigation display appeared to have collapsed and could not be displayed properly.Additional troubleshooting included replacing the connection cable and catheters, restarting the system, and performing revalidation, but the issue persisted.The issue was resolved by replacing the ensite x system with a non-abbott 3d system.The procedure was completed with no adverse consequences to the patient.

• Brand Name: ENSITE¿ X EP SYSTEM V3.1.1
• 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: 24254984
• Report Number: 2184149-2026-00027
• Device Sequence Number: 8467980
• Product Code: DQK
• UDI-Device Identifier: 05415067053121
• UDI-Public: 05415067053121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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-3.1.1
• Device Catalogue Number: ENSITE-SW-3.1.1
• 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: 01/09/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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