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

Model Number ENSITE-DWS-1.1

Device Problem Impedance Problem (2950)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, an impedance issue occurred and the procedure was cancelled.When attempting to ablate the cavotricuspid isthmus cti without anatomy (just with the help of the cs catheter), 0w displayed on the generator several times and the impedance rose to 999.The ampere generator had to be restarted twice, grounded, and a second neutral electrode had to be used.A loose contact was also noticed on the flexability.The procedure was more complex than expected, and several maps and had to be carried out.The patient became restless over time.The system displayed several warnings, including "voxel collection is suspended because the system has detected an impedance shift.Existing voxels were deleted to resolve the issue.Then, the field frame disconnected and could not be reconnected.The neck patch also showed as disconnected.The physician did not want to validate the examination again or carry out further troubleshooting.The procedure had to be stopped because the anatomical position was not reached.There were no adverse patient consequences.It is suspected the issue was the patient's fault as no similar problems have occurred since.

Manufacturer Narrative

The results of the investigation are 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.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported impedance issue occurred and subsequent cancellation could not be determined.

• Brand Name: ENSITE¿
• 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: 14712760
• MDR Text Key: 294531790
• Report Number: 2184149-2022-00145
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ENSITE-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8275729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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