MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X SOFTWARE V2.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-2.0.1
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During an atrial fibrillation procedure, there was a sheath filter and communication issues with the ensite x software, amplifier, and display workstation resulting in a delay.The ensite x amplifier was flashing red and the catheter was unable to be connected.It also kept showing that the catheter was in the sheath and no catheter data could be displayed.Additionally, during the procedure there was a contact force error with loss of the pressure value.During this the magnetic point would disconnect.After replacing the ensite x display workstation the contact force issue resolved.Troubleshooting also included replacing the catheter and restarting the ensite x display workstation at least 3 times, but the sheath filter issue persisted.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11 the reported event stated that ¿it also kept showing that the catheter was in the sheath and no catheter data could be displayed¿ occurred.Review of the ensite system documentation shows that sensitivity and specificity limitations that may cause the sheath filter to incorrectly hide a catheter.If the sheath filter is falsely detecting a catheter as in-sheath, it is recommended to reset the auto baseline.See ensite x ep system ifu, sheath filter.The reported event stated that "during the procedure there was a contact force error with loss of the pressure value," but that "after replacing the ensite x display workstation the contact force issue resolved." as the device was returned and investigated with no issues found, no software anomaly is suspected.The reported event stated that "the ensite x amplifier was flashing red and the catheter was unable to be connected." the amplifier was not returned, and troubleshooting of the returned device uncovered no communication issues with the amplifier.No software anomaly is suspected.

• Brand Name: ENSITE¿ X SOFTWARE V2.0.1
• 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: 23627065
• Report Number: 2184149-2025-00190
• Device Sequence Number: 13095521
• Product Code: DQK
• UDI-Device Identifier: 05415067046703
• UDI-Public: 05415067046703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231415
• 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): 02/17/2026

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-2.0.1
• Device Catalogue Number: ENSITE-SW-2.0.1
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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 AMPLIFIER.; ENSITE¿ X DISPLAY WORKSTATION.
• Patient Sex: Unknown