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

Model Number AFD-ENSITE-SW

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

During an atria tachycardia procedure using ensite x in navx mode, display issues occurred resulting in cancellation of the procedure.A map of the right atrium was done and when attempting to remap a new tachycardia, a map point with the catheter was not possible.The catheter was localized on the anatomy and the signal was visible, however an error was noted stating: "no location" on each egm.Respiration compensation was done twice and the catheter was unplugged and plugged back in, but the issue was not resolved and the procedure was cancelled.

Manufacturer Narrative

Review of the study data provided shows that the ensite x system thought the catheter was in the sheath when map2 was started.The cause of the reported display issue and subsequent cancellation were determined to be software related.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 SOFTWARE
• 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: 16022153
• MDR Text Key: 306330620
• Report Number: 2184149-2022-00304
• 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,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 01/12/2023
• 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