MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SEK-5-01
Medical Device Problem Codes	Communication or Transmission Problem (2896); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure with pulsed field ablation, there was a delay due to a patch connection issue resulting in the ensite system being restarted four times.After starting an ensite x study in navx mode, it was noted that an error of "left leg or ref electrode patch disconnected" would intermittently occur, as well as an intermittent "ampere disconnected" error.A "surface electrode impedance" error would also occur, after successfully validating the patches.Intra-cardiac signals could be seen on the ensite x system, but no catheter visualization.Respiratory compensation could also not be done.Additional ultrasound gel was applied first to the leg patch, then the system reference patch, with no resolution.A second patch kit was opened, and the left leg patch, and the system reference patch were placed in different locations on the patient but still did not resolve the issue.A secondary navlink was also tried, to no success.The ensite x system was rebooted four times, with no resolution.The procedure was completed using conventional non-mapping methods, and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
During the atrial fibrillation procedure with pulsed field ablation, there was a delay due to a patch connection and impedance issues resulting in the ensite system being restarted four times.After starting an ensite x study in navx mode, it was noted that an error of "left leg or ref electrode patch disconnected" would intermittently occur, as well as an intermittent "ampere disconnected" error.A "surface electrode impedance" error would also occur, after successfully validating the patches.Intra-cardiac signals could be seen on the ensite x system, but no catheter visualization.Respiratory compensation could also not be done.Additional ultrasound gel was applied first to the leg patch, then the system reference patch, with no resolution.A second patch kit was opened, and the left leg patch, and the system reference patch were placed in different locations on the patient but still did not resolve the issue.A secondary navlink was also tried, to no success.The ensite x system was rebooted four times, with no resolution.The procedure was completed using conventional non-mapping methods, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.One ensite x surface electrode kit left leg patch was received for evaluation.The patches displayed continuity with no open circuits detected.In addition, the leg patch was able to be validated with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event of connection and impedance issues remains unknown.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US)
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23763861
• Report Number: 3008452825-2025-00636
• Device Sequence Number: 10079194
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: (01)05415067032379(10)10964718(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K221213
• 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): 12/31/2025

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-SEK-5-01
• Device Catalogue Number: ENSITE-SEK-5-01
• Device Lot Number: 10964718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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