It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system.During mapping, it was reported that a map shift occurred on the carto 3 system.The procedure was completed with no patient consequence.Response received stated that there were no error/warning messages displayed on the carto 3 system.The position of the catheter did not correspond with the real position of the catheter in the heart.The difference in catheter location before and after map shift was 1.5 cm.It was also confirmed that no cardioversion was performed prior to the map shift.There was no evidence of patient movement.All tests were performed successfully after the map shift.No problem was found.Map shift was not reproduced during the next cases.The system is working according to specifications.According to the 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.The device history record (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.No: (b)(4).
|