The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max) and a non-penumbra intermediate catheter.It was noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while successfully placing the neuron max into the patient.Subsequently, the physician was unable to advance the intermediate catheter through the neuron max.Therefore, the neuron max was removed.The procedure was completed using a new neuron max and the same intermediate catheter.There was no report of an adverse effect to the patient.
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Evaluation of the returned neuron max could not confirm, the reported complaint.Evaluation revealed, that the neuron max was undamaged and functional.During functional testing, a demonstration ace60 was able to advance through the neuron max without an issue.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed.And did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.
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