MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X SOFTWARE V3.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-3.1
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia procedure, display issues with the ensite x software resulted in cancellation of the procedure.When using the ensite x system in voxel mode and mapping was done using the advisor hd grid catheter, everything was normal.However, when arriving at the anterior apical part of the left ventricle, the catheter had disappeared.Everything else remained the same and the green light was on but, only in that particular spot did the catheter disappear.Switching to navx mode caused the catheter to reappear but, after cardioversion, when the mode was switched back to voxel, the distortion meter was frozen in red.The mode was switched off voxel and the catheter was reinserted into the patient which resolved the distortion meter issue, but the catheter disappeared.Changing the catheter did not resolve the issue.After trying to map for a while longer, the decision to end the procedure was made due to the issue persisting.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event stated that "when arriving at the anterior apical part of the left ventricle, the catheter had disappeared" and ¿when the mode was switched back to voxel, the distortion meter was frozen in red.¿ the results of the investigation are inconclusive since the device was not returned for analysis.The case study was received for review; however, device logs were requested but were not provided.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: ENSITE¿ X SOFTWARE V3.1
• 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: 23012347
• Report Number: 2184149-2025-00150
• Device Sequence Number: 9741479
• Product Code: DQK
• UDI-Device Identifier: 05415067049704
• UDI-Public: 05415067049704
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 01/30/2026

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
• Device Catalogue Number: ENSITE-SW-3.1
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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