MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X SOFTWARE V2.0.1; WIRE, GUIDE, CATHETER

Model Number ENSITE-DWS-01

Device Problems Electromagnetic Interference (1194); Loose or Intermittent Connection (1371)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Related manufacturing reference: 2184149-2023-00134, 2184149-2023-00136.During the atrial fibrillation procedure, distortion, communication, and connection issues resulted in a procedural delay.At the start of mapping, a different position was tried for the patch but the distortion was noted to be below the threshold.The detector was moved away from the patient which did cause distortion to drop.However, the distortion started to exceed the threshold causing issues with the ablation/no vector available with the ablation catheter and unable to collect geometry during ablation.This occurred with no change in table height or x-ray position, no new equipment introduced.No change to the x-ray position was able to improve this.Again, the distortion temporarily resolved itself with no change to the environment.The patient reference sensor-a patch seemed to be picking up distortion with no change in the environment.The distortion exceeded threshold again, and this time it was temporarily improved by pressing on the patient reference sensor-a patch, indicating a connection issue between the patch and the patient reference sensor-a, resulting in communication issues between the patch and the patient reference sensor-a.The procedure was successfully completed but with delays of around 45 minutes to 1 hour.

Manufacturer Narrative

No investigation materials were provided.Abbott is unable to evaluate the product involved in this incident based on the information received.The cause of the reported incident could not be determined.

• Brand Name: ENSITE X SOFTWARE V2.0.1
• Type of Device: WIRE, GUIDE, CATHETER
• 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 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17266729
• MDR Text Key: 318649000
• Report Number: 3008452825-2023-00283
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 8068140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT; ENSITE¿ X PATIENT REFERENCE SENSOR