MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V3.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SW-03

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Application Program Problem (2880)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

During a ventricular tachycardia procedure display issues resulted in troubleshooting measures causing a procedural delay.Selecting the icon turned the display to green and resolved the issue and the procedure was completed with no adverse consequences to the patient.Using the ensite x, version 3, in voxel mode, the catheters would randomly freeze, outlined in red and suddenly appeared somewhere else.In some places the advisor hd grid was in the low confidence interval, even as there were enough voxels, and it was completely out of the lock.(e.G., posterior wall, roof).Despite having improved end-expiratory gating, model bloating occurred and had to delete a lot.The prs sensors were well bonded, however, they shifted after a cardioversion.A correction of the sensors was no longer possible, the result was an enormous mapshift, switching to navx mode resolved that issue and record a new anatomy and map which caused a 45-minute delay.Tactisys quartz display error (bottom right), even though the tactisys was on, everything was properly connected, validated and a tacticath se was selected in the setup, the tactisys was not displayed "green" in the bottom right.Clicking on the icon once to deselect and select for the display to turn green to resolve.The procedure was successfully completed with no adverse consequences to the patient.

Manufacturer Narrative

The study was provided and reviewed.The reported event stated that "the catheters would randomly freeze, outlined in red and suddenly appeared somewhere else".It is expected behavior that catheters freeze and are outlined in red if the catheter is outside the motion box or if data is invalid.One workaround that can be tried is reconnecting to the amplifier.Select the abbott menu button in the bottom left corner, select amplifier, then reconnect.Additionally, the user had difficulty with low confidence state and model bloating.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.Review of the ensite x cardiac mapping system verifies that in some cases a model bloat/false space can occur.

• Brand Name: ENSITE X SOFTWARE V3.0
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17778350
• MDR Text Key: 323804108
• Report Number: 2184149-2023-00189
• 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: 11/16/2023

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
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male