The patient was undergoing a thrombectomy procedure in the m2 inferior segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra microcatheter, and a guidewire.During the procedure, while advancing the red72 to the target vessel using the microcatheter for the first pass, the physician broke the red72 at the proximal end.Therefore, the red72 was removed.The procedure was completed using a new red72 and the same microcatheter.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 on its proximal end.If the red72 is advanced at an extreme angle during use, damage such as this may occur.Further evaluation revealed the internal coil winds unraveled.This damage was likely incidental to the reported complaint and may have occurred after removal of the device from 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.
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