MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X 4.0.1 SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-4.0.1
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pfa procedure, output issues resulted in a procedural delay.After collecting the voltage map with hd grid, the hd grid was withdrawn and the non-abbott pfa catheter (farawave by boston scientific) was inserted.Contact index baseline was started and the non-abbott catheter (farawave) pfa catheter flipped backwards in appearance even though it had not been physically moved.Pin location was checked; the catheter was removed from ensitex and a new one was loaded.The catheter presets were changed and respiratory compensation was performed with no resolution.The amplifier was reset and this did not fix the issue.The case was closed; the amplifier was turned off and the dws9 computer was rebooted.The case was restarted; rendering was appropriate but could not take shadows of the non-abbott (farawave) pfa catheter.Next the study was closed and the amplifier and dws9 were rebooted again and started a completely new case which resolved the issue.Rendering was appropriate and all tags and mapping worked.
Additional Manufacturer Narrative
The product's lot number could not be obtained; therefore, the primary di number is provided (d4), but full udi information is not available.

• Brand Name: ENSITE¿ X 4.0.1 SOFTWARE
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23681617
• Report Number: 2184149-2025-00202
• Device Sequence Number: 9846958
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/11/2026

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-4.0.1
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 06/11/2026
• 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
• Patient Sex: Unknown