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	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event stated that "the catheters began to intermittently disappear from the screen until they no longer appeared at all.¿ 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.Based on the information received, the cause of the reported incident could not be conclusively determined.The product's lot/serial number could not be obtained; therefore, the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During typical atrial flutter procedure using advisor hd grid in voxel mode, the catheters began to intermittently disappear from the screen until they no longer appeared at all resulting in a delay.The extensions were changed, the amplifier was restarted, and the catheters were switched to different channels, but they still did not appear.The mode was switched to navx, but the catheters continued to be absent from the screen.The case was restarted; however, when attempting to resume it, the system did not allow it because a message appeared on the screen stating that the patches had already exceeded the time limit to resume the procedure, even though the patch validation had been performed less than two hours earlier.It was attempted to resume under a new case, but it was not possible because the same message appeared on the screen.The patches were replaced, and since patches had already been validated with the hd grid mapping catheter and the tactiflex ablation catheter, both catheters had to be replaced because the system did not allow a new validation.The procedure was successfully completed with no patient consequences.

• 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: 24012154
• Report Number: 2184149-2026-00004
• Device Sequence Number: 18477490
• Product Code: DQK
• UDI-Device Identifier: 05415067053121
• UDI-Public: 05415067053121
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/08/2026

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: 12/10/2025
• Initial Report FDA Received Date: 01/08/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT.
• Patient Sex: Unknown