MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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 04/27/2022

Event Type  Injury  

Event Description

During an ensite x procedure in voxel mode for persistent atrial fibrillation ablation, a shift in the location of the catheters was noted, without associated prs-p error and prs positions looked fine.This was after mapping and ablation, and prior to cardioversion.The patient at the time was agitated and moving a lot and proceeded with cardioversion and were able to collect a new geometry to check lines of block.Subsequently, the patient developed a pericardial effusion a pericardiocentesis was performed which stabilized the patient.

Manufacturer Narrative

Review of the ensite x cardiac mapping system voxel mode confirms that in some cases a shift can occur.If a shift occurs, it is recommended to remove any metal that may be causing distortion.Additionally, use the prs setup screen to align the prss to the original location, reset metal baseline, or begin a new study.

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 14403008
• MDR Text Key: 294681607
• Report Number: 2184149-2022-00121
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/04/2022

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-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/14/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/04/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening