MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number AFD-ENSITE-SW

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194)

Patient Problem Cardiac Perforation (2513)

Event Date 11/11/2022

Event Type  Injury  

Event Description

Related manufacturing ref: (b)(4).During the parox atrial fibrillation, native atrial tachycardia, and typical atrial flutter procedure, there was a pericardial effusion, requiring drainage.The following issues with ensite x occurred during the procedure: when the procedure was started the system showed that the magnet was not connected.All of the cables were in place.The cable near the field frame was not properly connected and once that was fixed the amplifier started as normal.The prs-a was moved twice to set the metal baseline in a normal detector position.In voxel mode the metal baseline was set and there was a lot of voxel when mapping was started with the hd grid.But the catheter was in low confidence which appeared to be related to irregular respiration and being inside the veins.Respiration compensation was not working as intended and the respiration rejection had to be turned off to complete ablation and mapping.Point collection on the shaft caused false space and there was a lot of interpolation between the veins.There was a lot of complex substrate.The lap map picked up a lot of wrong points related to artifact, which was caused by turning off the enhanced noise rejection and due to the ventricular far-field.Outlaver helped but there was still a lot of incorrect color on the la anterior wall related to the ventricular far-field.The ablation catheter was intermittently red and was showing poor se quality.The connection cable was swapped, but the ablation catheter started to show temperature alarm in power control/temp cut off mode.The ablation catheter was swapped and the issue was resolved.The blood pressure dropped and an echo was done to confirm pericardial effusion.A pericardiocentesis was done and the ablation was continued and the model and map were correct.The procedure was successfully completed with no patient consequences.

Manufacturer Narrative

Study data was provided and reviewed.The reported event stated that "the catheter was in low confidence which appeared to be related to irregular respiration and being inside the veins".Collecting more voxels when entering a new area, such as a vein, will help increase the validity of the catheter.The catheter visualization changes depending on the density of voxels surrounding each catheter.When the density of voxels is low, the catheter will show in a low confidence state.When the density of voxels is high, the catheter will show in a high confidence state.See ensite ep ifu, sensor enabled¿ catheter visualization.The reported event stated that also stated that ¿respiration compensation was not working as intended and the respiration rejection had to be turned off to complete ablation and mapping¿.Abbott suggests monitoring the respiration waveform, if the waveform looks regular recollect the respiration compensation baseline.If the breathing pattern is shallow, then consider turning off respiration compensation, see ensite x ep system ifu, respcomp x.If catheter movement occurs, it is recommended to use conventional ep techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location, see ensite x ep system ifu layout, warnings.Additionally it stated ¿point collection on the shaft caused false space and there was a lot of interpolation between the veins¿ and "the lap map picked up a lot of wrong points".Review of the ensite x cardiac mapping system verifies that in some cases a model bloat/false space can occur.These are the recommendations to mitigate the model bloat/false space: ¿ ensure patches are properly connected.¿ consider using a low model fill value to minimize model surface interpolation.See ensite x ep system software ifu collect work panel, model sub-tab, finish model state ¿ consider lowering the velocity threshold.Catheters moving at fast speeds may contribute to model bloat/false space.See ensite x ep system software ifu velocity meter and velocity filter ¿ if encountering frequent irregular respiration (ir) detections, check connections of all patches and don¿t turn off ir rejection.Turning off ir rejection can allow data to be collected that can contribute to model bloat/false space.¿ if the shift and drift detection messages persist, consider the reset voxels option.Ignoring the shift and drift detection message may cause shifted data to be collected which can contribute to model bloat/false space.See ensite x ep system software ifu impedance shift ¿ if false sheath detection occurs frequently, re-baseline the sheath.See ensite x ep system software ifu sheath filter, re-baseline sheath filter ¿ if possible, keep/lower the metal distortion baseline threshold to level ii.The higher threshold one chooses, the less accurate the model will be.See ensite x ep system software ifu ensite¿ x ep system setup, system tab, metal sub-tab, distortion threshold level ¿ when moving a mapping catheter from one chamber to another, consider re-collect respiration compensation baseline.The effect of respiration on catheters may be different between chambers.See ensite x ep system software ifu collecting respiration data.¿ disconnect any out-of-body catheter.¿ in voxel mode, consider collecting voxels with a sensor enabled¿ ablation catheter prior to collecting model data with a sensor enabled¿ diagnostic catheter.It was also reported that "the catheter was in low confidence which appeared to be related to irregular respiration and being inside the veins".Collecting more voxels when entering a new area, such as a vein, will help increase the validity of the catheter.The catheter visualization changes depending on the density of voxels surrounding each catheter.When the density of voxels is low, the catheter will show in a low confidence state.When the density of voxels is high, the catheter will show in a high confidence state.See ensite ep ifu, sensor enabled¿ catheter visualization.Lastly, the report stated that ¿respiration compensation was not working as intended and the respiration rejection had to be turned off to complete ablation and mapping¿.Abbott suggests monitoring the respiration waveform, if the waveform looks regular recollect the respiration compensation baseline.If the breathing pattern is shallow, then consider turning off respiration compensation, see ensite x ep system ifu, respcomp x.If catheter movement occurs, it is recommended to use conventional ep techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location, see ensite x ep system ifu layout, warnings.

• Brand Name: ENSITE¿ X SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 15844937
• MDR Text Key: 304121656
• Report Number: 2184149-2022-00279
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFD-ENSITE-SW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿.
• Patient Outcome(s): Required Intervention