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

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an epicardial ventricular tachycardia ablation, in a patient with an implanted sicd, there was a delay due to mapping issues with the ensite x system.There were catheter location issues, but the patch validation was okay, and the check metal field and metal baseline were okay.It was not possible to collect geometry with the electrodes of the advisor hd grid mapping catheter.Acquisition was only possible with the catheter shaft and activation points were unable to be taken because the advisor hd grid mapping catheter was in no location.The kt was moved in various directions with no resolution.The patches were checked, the advisor hd grid mapping catheter and cable were changed, as well as the reference patch.The amplifier was turned off and all cables were disconnected from it and 20 seconds were plugged back in and the amplifier was turned back on, but the issue persisted.The procedure was finally performed in navx mode with no adverse patient consequences.The procedure was lengthened by one hour due to technical issues.
Additional Manufacturer Narrative
The reported event stated there was catheter location issue causing a procedure delay.Review of the provided study data confirms instances of the catheter being in a low confidence state.In multiple instances the low confidence was due to the catheter intermittently being in the sheath.A workaround is to collect a manual sheath baseline when the catheter is in the body, fully out of sheath, and set to visible.In another instance the prs-p baseline was not re-established, causing all advisor hd grid electrodes to remain in low confidence throughout the segment.The advisor hd grid was disconnected and reconnected to establish the baseline deleting all voxels prior to this segment.The catheter remained in low confidence again due to a lack of voxel data collected in the study to consistently reach high confidence.

• Brand Name: ENSITE¿ X 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: 17726623
• Report Number: 2184149-2023-00183
• Device Sequence Number: 6543417
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/09/2023

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-1.1
• Device Lot Number: 8340806
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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