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

Model Number ENSITE-SYSTEM-01

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

During a redo parox atrial fibrillation procedure, several issues occurred causing a procedure delay to occur.During the procedure, there were issues with respiration comp which caused irregular movement of the catheter as though movement was related to the regular and irregular breathing pattern.Additionally, there was false space related to incorrect rendering as well as issues with collecting model points in voxel mode.Mid procedure, the patient coughed, and 3 of the prsp became red even though they remained in a fixed position.In order to resolve the issue, the catheter was replaced with an advisor hd grid and respiratory comp was turned off.After these changes were made, the procedure was able to be completed with no adverse patient consequences.

Manufacturer Narrative

The event reported catheter movement related to irregular patient respiration and respiration compensation and model bloat.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: 12525783
• MDR Text Key: 273108241
• Report Number: 2184149-2021-00267
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1