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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2184149-2022-00254
• Device Sequence Number: 5965697
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT REFERENCE SENSOR 3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown