It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a mapshift occurred.It was reported that there was a map shift on the carto 3 when making a new map of the chamber.No error messages were displayed, there was no patient movement.The patches were also in place.No active troubleshooting could be performed, the case completed successfully.Additional information received confirm that no error messages were displayed when the issue occurred.The shift was noted when starting a new map.The patient was in the same rhythm as the previous map.It also confirms that cardioversion didn¿t occur prior to the map shift.A biosense webster inc.(bwi) field service engineer spoke to the bwi field representative and confirmed the mapshift occurred near the end of the case.
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a mapshift occurred.It was reported that there was a map shift on the carto 3 when making a new map of the chamber.No error messages were displayed, there was no patient movement.Product evaluation details the bwi field service engineer spoke with the bwi field representative and advised the occurred issue could be caused by the patient relaxing under sedation.No service requested by the account.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.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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