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

Model Number ENSITE-SYSTEM-01

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Cardiac Perforation (2513)

Event Date 03/02/2021

Event Type  Injury  

Event Description

Related manufacturer ref: 2184149-2021-00091, 3008452825-2021-00175, 3008452825-2021-00176, 3008452825-2021-00177, 3005334138-2021-00202.Following a pulmonary vein isolation ablation procedure for atrial fibrillation, a pericardial effusion was diagnosed via echocardiogram.The pericardial effusion was treated successfully and the patient was stabilized, however, it is unknown how it was treated.The patient's blood pressure was stable throughout the entirety of the procedure and there were no performance issues with any disposable devices.Per the physician, the reported oversized shell involving the ensite x may have contributed to the effusion.

Manufacturer Narrative

The case study was provided and reviewed for evaluation.Slight model bloat was observed in the areas of the pulmonary veins, however, it was determined that the model bloat was not out of the normal range of what is expected from data collection from a circular mapping catheter as the catheter can tent the tissue.

• 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: 11584747
• MDR Text Key: 242907282
• Report Number: 2184149-2021-00100
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K202066
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR VL, SE MAPPING CATHETER.; AGILIS STEERABLE INTRODUCER.; INQUIRY STEERABLE DIAGNOSTIC CATHETER.; SWARTZ TRANSSEPTAL INTRODUCER.; TACTICATH ABLATION CATHETER, SE.
• Patient Outcome(s): Required Intervention