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

Model Number ENSITE-SYSTEM-01

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

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

Event Date 09/17/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation (af) procedure, several issues occurred resulting in a procedure delay.While in voxel mode, respiration compensation was not working properly.Early metal baseline was taken and several voxels were taken before starting the model.Despite this, the location of the mapping catheter within the veins and laa was not certain.Additionally, there was false space related to rendering and respiration.Suddenly, the patient coughed, and two of the prs's turned red.When checked, all the sensors were fixed with tape and remained in the same position.After moving the position of the sensors, we were able to get them into a location where they appeared green on the system.However, after re-positioning, a shift was experienced and a new model and new procedure was started (in order to send case study).It took several minutes to connect the amplifier, and setup needed to be redone.Due to the restart, there was no voxel and the mapping catheter location remained in low confidence and the shape and location were incorrect.Model collection was difficult, and model bloat due to overestimating the size of the mapping catheter in the veins and the posterior wall.Additionally, there was intermittent catheter movement which did not reflect the real time movement of the catheter.The procedure was able to be successfully completed with no adverse patient consequences.

Manufacturer Narrative

The event reported catheter movement related to irregular patient respiration as well as false space related to issues with rendering and respiration.In reviewing the case, it was confirmed that in some cases a model bloat/false space can occur.Abbott suggests resetting the voxels option.Ignoring the shift and drift detection message may cause shifted data to be collected which can contribute to model bloat/false space.Additionally, some of the catheter movement seen was deemed to be actual catheter movement while other motion movement was confirmed to be attributed to respiration.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.If model bloat occurs, the ensite x cardiac mapping system instructions, has several troubleshooting methods outlined for mitigating the issue.

• Brand Name: ENSITE X EP SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12611775
• MDR Text Key: 280945921
• Report Number: 2184149-2021-00290
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1