MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM DISPLAY WORKSTATION; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contractions procedure there were mapping issues which resulted in a delay.While using the ensite x in navx mode, it was noted that when adding geometry with the tactiflex se ablation catheter after the rvot geometry was created and sensor enabled correction was done the geometry became thin.The navx compensation was used again, causing model bloat.Changing back to sensor enabled compensation, the geometry became thin again.When pacing with tactiflex se ablation catheter, sensing was not performed properly, and pacing could not be performed.The impedance of the tactiflex se ablation catheter was high, and the fluctuation of the baseline was intense even in the generator waveform.The tactiflex se ablation catheter was replaced with a new tactiflex se ablation catheter, and the pacing issue was resolved.However, the geometry issue persisted, so the tactiflex se ablation catheter was replaced with a tacticath se ablation catheter.However, the issue still persisted, so the second tactiflex se ablation catheter was eventually used to perform the rf delivery.It was "thought" that replacing the amplifier resolved the issue, however no performance issue was found during analysis.
Additional Manufacturer Narrative
The reported event stated that "the geometry became thin.The navx compensation was used again, causing model bloat" occurred.Abbott is unable to evaluate the product involved in this incident based on the information received.The cause of the reported incident could not be determined.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: 17218520
• Report Number: 2184149-2023-00128
• Device Sequence Number: 19589123
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 7908065
• 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: 06/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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
• Patient Sex: Unknown