The patient was undergoing a thrombectomy procedure in the right carotid artery and middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), a neuron max 6f 088 long sheath (neuron max), and a non-penumbra microcatheter.During the procedure, the physician made one pass in the target vessel using the red72.After the pass, the physician noticed there was clot inside of the red72 and decided to remove the red72 for flushing.While removing the red72, the physician noticed majority of the red72 was being pulled out from the sheath.The physician performed a fluoroscopy and noticed the red72 appeared to be fractured in the vessel.The proximal red72 was removed with the bmx96.The physician then placed a neuron max and snared the distal red72.The procedure was completed using a new non-penumbra aspiration catheter and a non-penumbra guide catheter.There was no report of an adverse effect to the patient.
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Evaluation of the returned red72 confirmed that the catheter was fractured and revealed that the catheter was stretched at the fractured location.This damage typically occurs due to retraction against resistance.Further evaluation revealed multiple kinks on both proximal and distal fracture segments.This damage may have also occurred during manipulation.The kink on the distal fracture portion of the red72 near the fracture location likely occurred while snaring.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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