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.Manufacture reference no: (b)(4).
|
It was reported that a patient underwent an ablation procedure for atrial fibrillation with the carto® 3 system and a map shift error occurred.At the beginning of the procedure the patient interface unit (piu) displayed contact force sensor error 106.The cable was changed from the piu, but the problem persisted.Replacement of the unk_smart touch bidirectional sf catheter resolved the issue.During ablation, after drug administration, the map shifted about 1.5 cm.Software version 6 was in use.The observed contact force sensor error 106 has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed map shift has been assessed as an mdr reportable malfunction as map shifted with no error message, patient movement, or cardioversion.
|