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

Model Number ENSITE-SYSTEM-01

Device Problems Erratic or Intermittent Display (1182); Application Program Problem (2880)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Related manufacturing ref: (b)(4).During an atypical atrial flutter (aafl) ablation in the left atrium using the ensite x system, the right atrium (ra), left atrium (la), and coronary sinus (cs) were mapped.Multiple maps were created as the cycle length and cs activation changed throughout the case.At approximately the 6 hour mark, the system froze and the screen was flashing.Prior to this, the ra was attempted to be loaded to review the complete aafl circuit in both the ra and the la.After a minute, a hard restart was performed on the cpu, which resolved the issue.At one point during the procedure, while ablating in the cs, the ablation contact force shot up to 400+g.The contact force was reset, but the contact force measurements did not appear.The catheter was exchanged and the issue was resolved.Due to the system freeze being unresolved and the overall procedure length, the procedure was abandoned.There were no adverse patient consequences.

Manufacturer Narrative

The case study, collect logs, and a video were provided and reviewed.Review of the provided data revealed the display issue was caused by an error that occurred when the respiration meter was displayed before data was provided for it.This leads to down-stream graphics becoming corrupted.It is recommended to avoid displaying wave meters before the data source for the meter is available.

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 14360927
• MDR Text Key: 293186587
• Report Number: 2184149-2022-00119
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• 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: TACTICATH¿ ABLATION CATHETER, SE