Results: the distal atraumatic tip of the neuron max was damaged.Bends were observed throughout the length of the neuron max.The packaging card and mandrel were not returned and could not be evaluated.Conclusions: evaluation of the returned neuron maxs revealed the distal atraumatic tips were damaged.This type of damage typically occurs due to improper handling during removal from the packaging.If the packaging mandrel become unsecured from the packaging card, it may pin the neuron max distal atraumatic tip between the packaging mandrel and the packaging tube upon retraction.If the neuron max is subsequently retracted while pinned, the distal tip will likely become damaged.Further evaluation revealed bends along the length of the neuron maxs.Based on the return condition, the bends were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters 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.This report is associated with mfr report numbers: 3005168196-2018-01202.
|
During preparation for a medical procedure, the hospital staff found that the two neuron maxs 6f 088 long sheath (neuron maxs) had slight tears at the distal tip upon removal from the packaging.The damages to the neuron maxs were found prior to use.Therefore, the neuron maxs were not used in the procedure.The procedure was completed using a new neuron max.
|