The patient was undergoing a thrombectomy procedure in the left common carotid artery (cca) and the left middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra guide catheter, and a guidewire.During the procedure, while the physician advanced the red72 over the guidewire through the guide catheter for the first pass, the physician noticed under fluoroscopy that the guidewire was not visible even though the physician was pushing forward the guidewire.The physician then decided to remove the red72 from the guide catheter to see the guidewire.While removing the red72, the physician experienced resistance.After removal of the red72, the physician noticed that the distal length of the red72 had fractured in two locations.It was reported that the guidewire had exited through the side of the red72 instead of the distal end of the red72.Therefore, red72 was not used for the remainder of the procedure.The procedure was completed using another aspiration catheter, the same guide catheter, and the same guidewire.There was no report of an adverse effect to the patient.
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Evaluation of the returned red72 confirmed fractures on the distal shaft.If the red72 is advanced against resistance, damage such as kinks and subsequent fractures may occur.This damage contributed to the reported guidewire exiting the side of the red72 during the procedure.Further evaluation of the red72 revealed ovalization on the distal shaft.This damage may have contributed to resistance during the procedure.Due to the fractures, the red72 could not be functionally tested.Further evaluation also revealed kinks along the length of the catheter.This damage was incidental to the complaint and may have occurred during packaging for return to penumbra.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.
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