The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital discarded the device.
|
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using an ace catheter.During the procedure, the physician advanced a filter wire into the patient¿s ica, and then advanced the ace catheter past the filter wire, using a neuron max 6f 088 long sheath (neuron max).While in the patient, the radiopaque marker on the ace catheter broke off and was floating in the middle cerebral artery (mca).The physician therefore removed the radiopaque marker using a non-penumbra stent retriever.There was no report of an adverse effect to the patient.
|