MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SYSTEM-01

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation case in voxel mode with an hd grid catheter, error messages were noted and a delay occurred.The catheters were stable during the procedure.Velocity had to be reduced to 15 to avoid model bloating.The patient reference sensors had to be stuck down, otherwise it moved with the slightest movement of the patient.The irregular respiration compensation had to be switched off in between because no mapping points could be collected.False points had to be deleted because the model was very bloated.The mapping window could only be set after an se catheter has been connected, no triggering possible before.The fixed proximity indicator was too small for the physicians and sometimes not correctly projected to the surface.The cables for the ecg's and the system reference are too short.The generator display moved to the upper right sight every time you change something.The visualization was not good (like in precision), especially when you click on one mapping point to see the signal, it's very difficult to see which point you choose.The visualization of the tacticath was very bad, because of the model bloating and the wrong display of the fixed proximity indicator.The physician couldn't see on which point the ablation catheter was.During the case the patient was very restless, and sedation had to be increases several times.The patient was sweating a lot and he was breathing very irregularly.The message that there is an impedance shift occurred a few times but after a short time it displayed that the impedance shift is resolved.But later you could see that there was a map shift and because of the many problems with the patient and the procedure finished prematurely.The left pulmonary veins were not isolated completely, and the right veins were not started.The procedure was finished without any patient consequences.The patient will be ablated again in a few weeks.

Manufacturer Narrative

The user reported irregular respiration issues, a bloated model, inability to set a mapping window after an se catheter has been connected, a small, fixed proximity indicator, and an impedance shift.Per the ifu, when irregular respiration is active, data points are rejected to not affect the weighting for respiration compensation, therefore the software is functioning as designed.A bloated model may occur and per the ensite x cardiac mapping system instructions, there are several troubleshooting methods outlined for mitigating the issue.The inability to set a mapping window was reported.An active catheter is needed to display the meters and to trigger on a surface.The issue can be resolved manually by selecting an active catheter.A small, fixed proximity indicator was reported.The size of the proximity indicator is correlated to the distance from the model surface; moving the catheter closer to the model surface or editing the model surface may make the proximity indicator easier to see.Proximity indicator also projects to the closest model surface, rotating the model may make the proximity indicator easier to see.Lastly, an impedance shift was reported.If a shift occurs, it is recommended to remove any metal that may be causing distortion.Additionally, use the prs setup screen to align the prss to their original location, reset metal baseline, or begin a new study.

• Brand Name: ENSITE X EP SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12526154
• MDR Text Key: 273123343
• Report Number: 2184149-2021-00299
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Device Lot Number: 8062343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1