MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number ENSITE-AMP-02

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

During a pulmonary vein isolation atrial flutter procedure, the ensite x amplifier went to a flashing amber status resulting in cancellation of the procedure.Despite multiple reboots and disconnecting everything from the front of the amplifier, the issue did not resolve.There were issues with model collection, electrical points, and catheter visualization.This occurred when using an ensite x mapping system with the new non-abbott recording system (ge cardiolab).When in navx mode, all the catheters would appear very slow and froze.When switching to voxel mode, the ablation catheters would either collect only voxels or they would appear as if they were in low confidence while surrounded by voxels.They would also appear as if inside a sheath while completely exposed.The sheath filter was not able to be reset any time.The whole system was power cycled several times and a new advisor hd grid catheter was used as a replacement, which did not resolve the issue.The new non-abbott (ge) pin pads were tried again and there was also no improvement.All the issues resolved after unplugging both horsetail cables from the ensite x amplifier.The issue only occurred when the horsetail was connected to the new pin blocks and the ensite x amplifier.Without the egm sharing between the non-abbott (prucka) system and ensite x mapping system, the ensite x mapping system performed as designed and there were no issues navigating catheters.A second amplifier was brought in that booted appropriately.The pulmonary vein isolation procedure was successfully completed, but it was not possible to map and terminate the flutter so it was decided to stop the procedure.The system functionality was tested with the two systems the day prior and there were no issues.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: g3, h2, h3.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17206128
• MDR Text Key: 317992943
• Report Number: 2184149-2023-00124
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K202066
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8906878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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