MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM V1.1.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SYSTEM-111

Device Problems Erratic or Intermittent Display (1182); Output Problem (3005)

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

Event Date 02/11/2022

Event Type  malfunction  

Event Description

During the redo atrial fibrillation of posterior wall isolation and atypical atrial flutter procedure, the system lost the mapping catheter location.Disconnecting, removing, and reconnecting the catheter appeared to solve the issue initially, but later in the case when a redo of the map was attempted, the catheter location was lost and could not be restored.The issue was not resolved and the procedure was cancelled.There was no patient consequences.

Manufacturer Narrative

The case study, collect logs, and photos were provided and reviewed.In regard to the 'no location messages', the system was operating as designed in those instances.After the metal baseline was reset, the voxel cloud was removed leading to the 'no location' messages even though the gumballs were green.In regards to the catheter location, review of the files showed the user set the visibility of the abl catheter to not visible, and from this point on, no catheters can be visualized in the study.In this, or any later segment, if the visibility of the abl catheter is set on, then catheters including the hd catheter can be visualized.It is recommended to turn on the visibility of the abl catheter in order to be able to visualize all catheters.

• Brand Name: ENSITE¿ X EP SYSTEM V1.1.1
• 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: 13769966
• MDR Text Key: 287188453
• Report Number: 2184149-2022-00047
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-111
• Device Lot Number: 8199365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG