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

Model Number ENSITE-DWS-01

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Cardiac Perforation (2513)

Event Date 10/14/2022

Event Type  Injury  

Event Description

Related manufacturing ref: 2184149-2022-00255.During the atrial fibrillation procedure, a pericardial perforation occurred after an issue with the prs-p sensors changing positions due to patient coughing and body movement while mapping in the left atrium.Due to the change in position of the sensors the system could not collect any information such as geometry.The sensors on the patient's back were then fixed with adhesive, but after this the patient became hypotensive and a perforation was found in the left atrium via an echocardiogram.A pericardiocentesis was performed and the patient was stable when the case was cancelled.The physician alleges the issue was due to the bad performance of the system.

Event Description

During the atrial fibrillation procedure, a pericardial perforation occurred after an issue with the prs-p sensors changing positions due to patient coughing and body movement while mapping in the left atrium.Due to the change in position of the sensors the system could not collect any information such as geometry.The sensors on the patient's back were then fixed with adhesive, but after this the patient became hypotensive and a perforation was found in the left atrium via an echocardiogram.A pericardiocentesis was performed and the patient was stable when the case was cancelled.The physician alleges the issue was due to the bad performance of the system and poor performance of the prs-p sensors due to loose adhesive and instability.

Manufacturer Narrative

Additional information: b5, g3, g6, h2, h3, h6 the reported event stated "a pericardial perforation occurred after an issue with the prs-p sensors changing positions due to patient coughing and body movement while mapping in the left atrium." occurred.The case study and collect log files were provided and reviewed.Review of the provided files show no unexpected system behavior was observed.The rf auto segments were reviewed with no unexpected behavior being observed.There were repeated prs-p diverged flags logged related to patient movement.All catheters appear to have remained in the body during this time interval.Patient movement detected on prs-ps prevents data collection by the system.It is recommended to ensure the prs sensors are located within the motion field and adjust prs placement.See ensite x system ifu, ensite¿ x ep system setup, system tab - prs sub-tab.The software is functioning as designed.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15651249
• MDR Text Key: 302191610
• Report Number: 2184149-2022-00254
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/29/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7885532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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
• Treatment: PATIENT REFERENCE SENSOR 3
• Patient Outcome(s): Required Intervention