MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY DWS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number EE3000

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Cardiac Perforation (2513)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

Post procedure, a pericardial effusion was noted.During the pulmonary vein isolation procedure, the workstation/display froze.The dws was restarted and the study resumed, but there was no automark, therefore, the procedure continued without automark.Following the procedure, when performing an echocardiogram, an effusion was noted.A pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

The results of the investigation were inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.Based on the information received, the cause of the pericardial effusion remains unknown.

• Brand Name: ENSITE VELOCITY DWS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13017383
• MDR Text Key: 282325630
• Report Number: 2184149-2021-00410
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: EE3000
• Device Lot Number: G700795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1