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Model Number ENSITE-SYSTEM-01 |
Device Problems
Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Event Description
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During a pulmonary vein isolation procedure, catheter movement prevented the successful ablation of the right inferior pulmonary vein.In voxel mode, excessive movement was observed in the coronary sinus that was not mimicking the cardiac motion.Cardiac pacing and recollecting the respiratory compensation was attempted with no resolution.Additionally, the location of the magnetic sensor on the hd grid was incorrect and it was not possible to create the map.The catheter had glitchy motion when moving from high to low confidence states.The ablation catheter was also unable to be visualized in voxel mode.Excessive motion was observed on the ablation catheter in navx mode with ablation.The right inferior pulmonary vein was unable to be isolated due to the catheter motion.There were no adverse patient consequences.
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Manufacturer Narrative
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Additional information: g3, g6, h2, h3, h6.Four studies were provided and reviewed for this reported event. review of the study data shows that the catheter and electrode movement was coming from a software issue with the respiration compensation algorithm.Based on the investigation performed and the information provided, the cause of the reported event was traced to a known software issue.
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Search Alerts/Recalls
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