The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure in the pulmonary artery using a lantern delivery microcatheter (lantern).During the procedure, while advancing a lantern through a non-penumbra sheath, the physician experienced resistance and subsequently, the lantern became bent; therefore, it was removed.The procedure was completed using another microcathetrer and the same sheath.The physician also attempted to advance the lantern through the sheath after the procedure on the back table but the lantern would not advance.There was no report of an adverse effect to the patient.
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