It was reported a patient underwent an atrial flutter (afl) procedure with a carto 3 system and a map shift issue occurred.No cardioversion was performed, and no patient movement was noted.No error messages were given by the carto 3 system.No patient consequences were reported.Device evaluation details: the device evaluation has been completed.The bwi representative informed the bwi field service engineer (fse) that the shift seemed to be caused by the patient being given adenosine.According to carto 3 instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.As in this case the patient being given adenosine which could cause such kind of movement.The user used a work around and a new map was created; the case completed successfully.System is ready for use.The map shift had not reoccurred in later cases, no service requested.Dhr review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer¿s ref # (b)(4).
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