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

Model Number AFD-ENSITE-SW

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

Related manufacturing ref: 3008452825-2023-00145.During a redo case of persistent atrial fibrillation, there was a delay in the procedure due to location issues with the patient reference sensors.The procedure was successfully completed with no adverse consequences.1.When starting the case after validation, there were multiple error messages regarding impedance.The patches were checked, cables reseated, left leg patch was disconnected and revalidated, which resolved the issue.2.Respiration compensation could not be completed, and the system should an unsuccessful error.The meter had no curve and only a dotted line.It was reattempted multiple times, but it did not resolve.3.End exp gating was possible, however there was still false space.The velocity had been reduced to 30.4.The patient coughed, and the prs-p turned red.It was attempted to fix them, but it was noticed that one sensor in particular was loose on the skin.The location of the patch would change with movement.The second patch was high on the shoulder.The patches were replaced, and the procedure was restarted.5.Two prs-p were repositioned and when the case was started the system showed that the magnets were off.6.The case was restarted again, and the issues resolved.The procedure had been delayed about 60 minutes thus far due to the technical issues and having to redo the map of the left atrium.7.During the rest of the procedure, respiration compensation and shaky catheter issues led to false space.The positional influence of the respiration pattern on the catheter localization was visible.End exp gating was used, but there was still false space due to incorrect catheter localization.8.The advisor hd grid catheter was in low confidence, mainly inside the veins and the laa, despite there being lots of voxel.Respiration compensation was switched off which helped.9.Point collection of the catheter shaft caused false space, mainly internal holes but there was also false space at the posterior wall.Especially the vein ostia were not well defined.

Manufacturer Narrative

The case study was provided and reviewed for the investigation.The reported event stated that "respiration compensation could not be completed, and the system should an unsuccessful error.".Review of the files show bio impedance scaling was auto-disabled due to unreliable data.However, this was done without notifying the user.Without bio impedance scaling respiration compensation cannot be collected.A workaround to resolve the issue is to start a new study or revalidate to enable bio impedance scaling.Abbott is aware of the issue involving the user not being notified and is working on a resolution.The reported event stated that the user experienced false space.Review of the ensite x cardiac mapping system verifies that in some cases a model bloat/false space can occur.The reported event stated that the user had difficulty with low confidence state.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, including the tip.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.

• 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: 16676162
• MDR Text Key: 312678445
• Report Number: 2184149-2023-00076
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• 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: 04/13/2023
• 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: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT.