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

Model Number AFD-ENSITE-SW

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

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

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

The study data was provided and reviewed.The reported event stated that "the catheters were in low confidence at multiple times when the patient had a variable respiration curve." 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 ¿there was an error message "voxel collection is suspended because the system has detected an impedance shift." review of the ensite x cardiac mapping system voxel mode confirms that in some cases a system detected impedance shift can occur.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 the original location, reset metal baseline, or begin a new study.See ensite x ep system ifu, setup, system, prs sub-tab.The reported event stated that "when the catheter made a big movement, it froze, displayed red electrodes, and displayed in a new position.¿ review of the ensite system shows that when the catheter electrodes turn red, the catheter location cannot be updated and the catheter will appear stationary.See ensite x ep system ifu modeling, sensor enabled¿ catheter visualization.The software is functioning as designed.

Event Description

During an atrial fibrillation procedure, there were issues with making the maps resulting in cancellation of the procedure.The following issues were noted with the ensite x system: the catheters were in low confidence at multiple times when the patient had a variable respiration curve; there was an error message "voxel collection is suspended because the system has detected an impedance shift." when respiration returned to normal, the impedance shift was resolved; when the catheter made a big movement, it froze, displayed red electrodes, and displayed in a new position.The transseptal puncture was physically lost and the catheter was out from the left atrium and in the right atrium because of this issue.The physician physically maneuvered the catheter to find the transseptal hole again.The number of times these issues occurred resulted in the physician not being able to make maps.The voxels were attempted to be deleted, and respiration was unchecked, but this did not resolve the issue.There were no adverse patient consequences.

• 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: 15946605
• MDR Text Key: 305609860
• Report Number: 2184149-2022-00290
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 11/25/2022
• 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