MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X SYSTEM; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	ENSITE-SYSTEM-111
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2024-00057, 2184149-2024-00022, 2184149-2024-00017.During an atrial fibrillation procedure, the 3rd party non-abbott amplifier (prucka 3.0) would not pass the self-test, the ensite x amplifier, ensite x right leg patch, and fiber optic cable experienced communication issues, and the ensite x system color mapping was not working properly, resulting in delay of the procedure.When the navigation mode was changed from navx mode to voxel mode, it was reported that the non-abbott amplifier (prucka 3.0) orange led light blinked and did not turn to the green light.The non-abbott amplifier (prucka 3.0) was powered off and all the cables were disconnected from the front panel and then re-power on, then it went to the green light.The ensite x amplifier to ensite x display workstation communication error came up several times.It was then attempted to re-connect the lc cable with no resolution.The lc cable was then exchanged, temporarily resolving the issue.There was also a field frame generator communication error that came up.The non-abbott amplifier (prucka 3.0) and field frame generator were re-connected and rebooted several times and the issue resolved.The respiration button was attempted, but a patch impedance error came up.A right leg patch disconnected error message appeared, so the right leg patch was exchanged, resolving the issue.Geometry collection was then completed, however, there was an issue with the color mapping.It was attempted to reset metal distortion, re-collect respiration, re-validation, resume the study, collect voxel, and moving the catheter to voxel to a high-density zone without resolve.The procedure was then completed using a 3rd party system with no adverse patient consequences.The issues were alleged to be due to the non-abbott amplifier (prucka 3.0), ensite x amplifier, ensite x right leg patch, fiber optic cable, and ensite x system.
Additional Manufacturer Narrative
The case study and collect logs were provided and reviewed.The reported event stated that "there was an issue with the color mapping" occurred.Review of the files confirmed the event occurred.In the study it was observed that all captured map points were marked as 'no location', and in all the segments the hd grid catheter was shown as low confidence.The root cause of no location cannot be determined certainty; however, it may be due to broken catheter electrodes, broken cable or broken amp port impedance channel.The system is operating as designed.

• Brand Name: ENSITE¿ X SYSTEM
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18585210
• Report Number: 2184149-2024-00023
• Device Sequence Number: 18193582
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/28/2024

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-SYSTEM-111
• Device Lot Number: 9013481
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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; ENSITE¿ X AMPLIFIER; FIBER OPTIC CABLE LC/LC 30M
• Patient Sex: Unknown