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 11/30/2023

Event Type  Injury  

Event Description

Related manufacturing reference: 3005334138-2023-00557.During an atrial fibrillation procedure, a pericardial effusion occurred requiring a pericardiocentesis to stabilize the patient.When the ablation catheter was inserted into the patient for the first time, the default sheath filter on ensite x version 3.0 did not recognize the catheter as "out of the sheath", despite all four of the electrodes being out of the sheath as confirmed by intracardiac echocardiogram, impedance and electrograms.The sheath filter needed to be manually reset in order to visualize the catheter.Shortly after the transseptal puncture, a blood pressure drop was noted, and a pericardial effusion was confirmed around the right ventricle via intracardiac echocardiogram.The procedure was stopped, a pericardiocentesis was performed and the patient recovered with no further consequences.The likely cause was an instance of high contact force in the left atrial appendage with the ablation catheter.Only 7 rf lesions were delivered prior to abortion of the ablation procedure, in which no abnormalities (high force or impedance/temperature rises) were noted.There are no reported performance issues with the ablation catheter.

Manufacturer Narrative

The case study and collect logs were provided and reviewed.From the review of the files, it is observed that the catheter was momentarily outside of the sheath but went back in the sheath while attempting to collect the sheath baseline, leading to the sheath baseline not being collected.The sheath filter set baseline requires that all electrodes be out of the sheath.See ensite x ep system ifu, sheath filter.The system was operating as designed.

• 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: 18286044
• MDR Text Key: 329994316
• Report Number: 2184149-2023-00237
• 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: 03/11/2024

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: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/11/2024
• 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
• Treatment: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 80 KG