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

Model Number ENSITE-AMP-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 02/19/2021

Event Type  Injury  

Event 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.

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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11632031
• MDR Text Key: 244377721
• Report Number: 2184149-2021-00099
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032157
• UDI-Public: 05415067032157
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR VL; AGILIS INTRODUCER; INQUIRY CATHETER; SWARTZ INTRODUCER; TACTICATH SE; ADVISOR VL; AGILIS INTRODUCER; INQUIRY CATHETER; SWARTZ INTRODUCER; TACTICATH SE
• Patient Outcome(s): Required Intervention