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 disposed of the device.
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The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician placed a non-penumbra coil in the target vessel using a non-penumbra microcatheter.While placing a smart coil in the target vessel, approximately five millimeters of the proximal end of the smart coil stopped taking its intended shape; therefore, it was removed.The physician then successfully placed two other coils and a smart coil in the ica.While attempting to advance a non-penumbra coil into the microcatheter, the physician experienced resistance near the hub of the microcatheter.The physician then pushed the guidewire into the microcatheter with some resistance and the guidewire stopped approximately five centimeters from the distal tip of the microcatheter.Therefore, the physician removed the microcatheter and the guidewire altogether from the patient¿s body.Upon flushing the microcatheter, a red-colored foreign object that looked like thrombus came out of the microcatheter.The procedure was completed using another microcatheter and coils.There was no report of an adverse effect to the patient.
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