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

Model Number ENSITE-SYSTEM-01

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

Patient Problem Cardiac Perforation (2513)

Event Date 05/19/2021

Event Type  Injury  

Event Description

During the end of a pulmonary vein isolation (pvi) ablation procedure, an effusion occurred.While performing touch-up ablation at the la ridge, while in voxel mode, the system was unable to define the la ridge due to presence of geo bloat.The patient then became hypotensive and ice reveled an effusion in the la.A pericardiocentesis was performed to stabilize the patient.The patient is currently in stable condition.It was thought that the geo bloat on the system contributed to the reported event.

Manufacturer Narrative

Additional information: g3, g6, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.Abbott is unable to evaluate the product involved in this incident since the electronic files from the reported event date were not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.

• 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: 11995210
• MDR Text Key: 256686961
• Report Number: 3008452825-2021-00299
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067027665
• UDI-Public: 05415067027665
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Device Catalogue Number: A-TCSE-FJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 77