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

Model Number	ENSITE-AMP-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report numbers: 3005334138-2021-00197, 3008452825-2021-00170, 3008452825-2021-00171, 3008452825-2021-00172, 3005334138-2021-00198.Several hours following a pulmonary vein isolation (pvi) ablation procedure, a pericardial effusion was noticed.Following the procedure, while using the ensite x in voxel mode a pericardial effusion was detected.During the procedure, the patient was in stable condition and the pvi was completed with no adverse patient consequences.Several hours after the procedure, the patient became hypotensive, and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.The cause and location of the effusion remains unknown.Per the physician, the reported oversized shell involving the ensite x may have contributed to the effusion.The patient is currently in stable condition and has been discharged.
Additional Manufacturer Narrative
Review of the received study has shown slight model bloat was observed in the areas of the pulmonary veins, nothing was out of the ordinary of what is expected from data collection from a circular mapping catheter as this catheter can tent the tissue.High contact force values were observed in the case.Abbott recommends when model editing, collection of respiration compensation baseline with good respiration data, avoid tissue tenting, field scaling and model assessment/editing based on contact force data from the tacticath se catheter.Based on the investigation performed and the information provided, the cause of the reported event remains unknown.

• Brand Name: ENSITE X EP SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11632031
• Report Number: 2184149-2021-00099
• Device Sequence Number: 3496122
• Product Code: DQK
• UDI-Device Identifier: 05415067032157
• UDI-Public: 05415067032157
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: ENSITE-AMP-01
• Device Catalogue Number: ENSITE-AMP-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR VL; AGILIS INTRODUCER; INQUIRY CATHETER; SWARTZ INTRODUCER; TACTICATH SE; ADVISOR VL; AGILIS INTRODUCER; INQUIRY CATHETER; SWARTZ INTRODUCER; TACTICATH SE
• Outcome Attributed to Adverse Event: Required Intervention