MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM V1.1.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SYSTEM-111
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an ischemic ventricular tachycardia (vt) procedure, the ensitex system experienced metal distortion issues and the case was cancelled.At the beginning of the study, the metal field was checked in the recommended position and there were no issues.When setting the metal baseline in ap at a working height, distortion was already beyond 2.The physician raised the image intensifier slightly and set the metal baseline again, which set the distortion threshold to 1.The physician wanted to be prepared to use fluoroscopy since this was his first vt with our system.As the ablation catheter was being placed in the right atrium, initial geometry was collected with no issues.The physician then wanted to reprogram the device so he put the wand in the field to do so.During this time the metal threshold was jumping between 2-3 and the ablation catheter was shaking (this may be normal due to the wand temporarily being over the device).However, once the wand was removed from the field, the distortion was still sitting past 3.The metal baseline had to be reset and lose the ra geometry and proceeded to go transseptal.After transseptal, the ablation catheter was placed in the la and geometry collection began.After about one minute, the metal distortion exceeded the limit and collection could not continue.The physician did not move the fluoroscopy machine, nor was anything introduced into the field.The amplifier was turned off to let it reboot, the catheter was unplugged and deleted it from the system to let it auto populate again.The magnet was plugged back in, and the fluoroscopy machine was adjusted which did not resolve the issue so the metal baseline again.The metal distortion was sitting at 1 so we then proceeded to collect geometry in the lv with the ablation catheter and exchanged for grid with no problem.After mapping with hd grid, the catheter was exchanged back to the ablation catheter, and moved the fluoroscopy a few inches and metal distortion exceeded the threshold again.Collection could not continue and the image intensifier had to be readjusted to recollect again.At one point, the patient moved and because we wanted to continue collecting, we had to reset the metal baseline for a third time and recollect the lv geometry with ablation.A quick geometry and activation map were done with the ablation catheter, but after a few minutes metal threshold exceeded 2 and we could no longer collect.By this time, ablation was done where needed to finish the procedure.The patient was still going into vt post procedure.Overall, the metal baseline has to be reset 3 times during the procedure and the system was overly sensitive to any movement (or no movement at all) to fluoroscopy.The threshold would exceed 2 randomly throughout the procedure without touching/moving anything and we were adjusting fluoroscopy every few minutes.There was no harm to the patient during the procedure.
Additional Manufacturer Narrative
The reported event stated that the user experienced out of range metal distortion.The collect logs were provided and reviewed; the study data was not returned.The cause of the metal distortion and subsequent cancellation remains unknown.If metal distortion occurs, adjusting the metal environment near the patient such as raising the flat detector may resolve the issue.

• Brand Name: ENSITE¿ X EP SYSTEM V1.1.1
• Common Device Name: 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: 16815240
• Report Number: 2184149-2023-00088
• Device Sequence Number: 5682734
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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-SYSTEM-111
• Device Catalogue Number: ENSITE-SYSTEM-111
• Device Lot Number: 8608546
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 41 KG