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

Model Number ENSITE-DWS-01

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

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure in voxel mode, difficulty was noted recording the anatomy and a delay occurred.Mapping had to be done in the two lower veins because points could not be collected with the catheter in the veins.Editing the map took extra time due to model bloating.Irregular respiration had to be switched off, otherwise points would not have been collected.After the catheter was introduced into the left atrium, the sheath filter had to be reset manually since was out of the sheath on fluoroscopy, but not invisible.There were no consequences to the patient, however the procedure took longer than necessary.

Manufacturer Narrative

Review of the ensite x cardiac mapping system verifies that in some cases a model bloat/false space can occur and there are recommendations to mitigate the model bloat/false space.Review of the ensite system shows that when irregular respiration rejection is active, data points are rejected to not affect the weighting for respiration compensation.The software is functioning as designed.Abbott is aware of sensitivity and specificity limitations that may cause the sheath filter to incorrectly hide a catheter.If the sheath filter is falsely detecting a catheter as in-sheath, it is recommended to reset the auto baseline.See ensite x ep system ifu, sheath filter.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• 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: 13891228
• MDR Text Key: 288858460
• Report Number: 2184149-2022-00087
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 8058415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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