The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system red 62 reperfusion catheter (red62), a stent retriever, and a guidewire.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician completed one pass using the neuron max, red62, and stent retriever.Upon removal of the red62 and stent retriever, the physician noticed that the distal length of the red62 was fractured.The procedure was successfully completed at this point.There was no report of an adverse effect to the patient.
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Evaluation of the returned red62 confirmed that the catheter was fractured.The damage at the fracture location suggests this fracture occurred as a result of a kink.Based on the reported event, this damage likely occurred during removal from the patient after the completion of a successful pass.If the device is manipulated at an angle during removal, damage such as this may occur.The reported tortuous patient anatomy may have contributed to resistance during the procedure.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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