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Model Number ENSITE-SYSTEM-01 |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
Event Type
malfunction
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Event Description
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During an atrial fibrillation procedure, the catheter froze multiple times and was not moving at excessive speed.The procedure was completed with no consequences to the patient, however a delay occurred due to catheter freezing.
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Manufacturer Narrative
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Results of the investigation are inconclusive as nothing was retuned for review.However, review of the ensite system shows that se catheters freeze and electrodes turn red when either the magnetic data is invalid or the se catheter is outside of the motion box.In either case, the catheter location cannot be updated and it will appear stationary.The cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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