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 device was implanted into the patient.
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The patient was undergoing a coil embolization procedure in the cavernous segment of the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached a smart coil into the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and decided to remove the coil; however, upon retraction, the smart coil unintentionally detached.Therefore, the physician used the smart coil pusher assembly to push the detached coil out of the microcatheter and into the aneurysm.The procedure was completed using additional coils.There was no report of an adverse effect to the patient.
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