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

Model Number AFD0438

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Type  malfunction  

Event Description

During an atrial fibrillation (af) paroxysmal ablation procedure, a pericardial effusion occurred.After placing the mapping and ablation catheter in the right atrium, the catheter was showing distortion.The tip of the catheter was deflected down and on the system it showed the tip was pointing upward.The mapping catheter showed elongation of splines after setting baseline of the sheath filter.After retaking the respiratory compensation, the image was normal.After the double transseptal puncture, the left atrium was mapped.Ice was checked after mapping and a pericardial effusion was noted and the patient became hypotensive.The mapping catheter was removed, and a pericardiocentesis was performed to stabilize the patient.It was thought the effusion occurred while mapping in the la due to incorrect catheter appearance on the ensite system.The patient is currently in stable condition and has been discharged.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned and no log files/case study was provided.Based on the information received, 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: 11633473
• MDR Text Key: 244404166
• Report Number: 3005334138-2021-00206
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AFD0438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention