The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref #: (b)(4).
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and map shift issue occurred.It was reported that during the procedure, while mapping the right veins, the carto® 3 system had a significant map shift anterior and superiority.The metal values were low.A new map was started but the map shifted again more in line with the original map.The carto® 3 system did not display any error message.No pacemaker programmer or other type devices used.Patient did not move and there was no cardioversion that occurred prior to the map shift; the patient was strapped to the table.The movement was described as significant at approximately 2mm.There was no patient consequence reported.
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and map shift issue occurred.It was reported that during the procedure, while mapping the right veins, the carto® 3 system had a significant map shift anterior and superiority.The metal values were low.A new map was started but the map shifted again more in line with the original map.The carto® 3 system did not display any error message.No pacemaker programmer or other type devices used.Patient did not move and there was no cardioversion that occurred prior to the map shift; the patient was strapped to the table.The movement was described as significant at approximately 2mm.There was no patient consequence reported.Device evaluation details: the device evaluation has been completed.The biosense webster inc.Field service engineer (fse) was informed by the bwi representative that rebooting the workstation and using a default template resolved the reported map shift issue.The case completed successfully, and the system is operational.The customer declined system testing.The device manufacturer requested the study data related to the reported issue for further evaluation, however, the bwi representative reported that the data was no longer available since it was previously deleted.As a result, the root cause of the reported map shift issue was not determined.The bwi representative confirmed that there have not been any issues since and the account continues to use the system.A manufacturing record evaluation was performed for the system 14637, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref: (b)(4).
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