MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V3.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SW-03

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Cardiac Perforation (2513)

Event Date 12/04/2023

Event Type  Injury  

Event Description

During the atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis to stabilize the patient.Approximately halfway into the study, while using ensite x in voxel mode with an hd grid catheter, the electrodes turned yellow, and it was no longer possible to get se points.The navx location was working correctly, and other sensor enabled catheters worked correctly.There were no bent pins noticed in the port.The mapping catheter was replaced, but the issue remained.The egms appeared normal.The case was switched from voxel mode to navx mode in order to overcome the mapping issue and complete a map.A couple of failed attempts were noted while moving the ablation catheter to the posterior wall to start waca lines, the ablation catheter actually went more anterior with high forces.The physician requested to turn off the sheath filter because he believed it was not accurate.The sheath filter was put back on per physician's request and the ablation catheter was successfully positioned posteriorly.One lesion was placed for less than 10 seconds when a drop in blood pressure was noted.A pericardial effusion was confirmed on the lateral wall of the ventricle using ultrasound and ice and a pericardiocentesis was performed to stabilize the patient.The physician believed the effusion could have occurred when handling the non-abbott sheath (carto vizigo) and the mapping catheter since the ensite sheath filter was not showcasing proper sheath location with regard to the catheter.He did this procedure without fluoroscopy.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 review of the collect logs was unable to confirm the event.No anomalies were noted in the collect logs indicating low confidence or yellow electrodes, and no shift was noted.Based on the investigation performed on the provided files, the system is operating as designed.The cause of the reported event remains unknown.

• Brand Name: ENSITE X SOFTWARE V3.0
• 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: 18397532
• MDR Text Key: 331373221
• Report Number: 2184149-2023-00245
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• 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: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/06/2024
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White