During preparation for a coil embolization procedure, the interventional radiologist found that the three neuron 6f 070 delivery catheters (neuron 070s) were broken at multiple points upon removal from the packaging.The damages to the neuron 070s were found prior to use.Therefore, the neuron 070s were not used in the procedure.The procedure was completed using a new neuron 070.
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Results: the neuron 070 product display box was damaged.The packaging card was creased.The neuron 070 was ovalized approximately 68.5 cm from the hub.The device was kinked approximately 17.0 and 20.5 cm from the hub.The complaint did not involve device functionality, therefore, functional analysis was not performed.Conclusions: evaluation of the returned neuron 070s revealed ovalized devices.The product display boxes and packaging cards were creased and damaged.This damage likely occurred due to improper handling during transit from penumbra to the hospital.Further evaluation revealed kinks on the devices.If the device is forcibly manipulated at extreme angles from the packaging tube, damage such as a kink may occur.Penumbra catheters and product display boxes are visually 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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