It was reported that a patient underwent a right atrial flutter procedure with a carto® 3 system and a map shift without error message occurred.During mapping, there were high temperatures of 43°c being displayed by the catheter.The temperature cutoff was 43°c and the generator stopped ablation when the cutoff was reached.The catheter was removed from the body and it was then noticed that it was not flushing properly.The catheter was replaced and the issue resolved.When the replacement catheter was inserted into the body, it was noticed that the catheter appeared outside the map shell and therefore a map shift had occurred.There was a significant difference in the catheter location before and after the map shift.The new location was higher on the screen than the old one.There were no metal errors or warnings displayed.A new map was created; the procedure was continued and subsequently completed with no patient consequence.This event is mdr reportable because map shifts with no error message could potentially cause a potential risk to the patient.The high temperature and irrigation issue is not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.
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