Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The shelf box and device pouch were visually inspected.Visual examination revealed that the seal on the shelf box is open.The device pouch was taken out and inspected and it was verified that the device pouch has been open.The dfu manual that goes with the device is no longer in the shelf box.On the back of the device pouch there is a vertical cut on the white section 114mm from the left side and approximately 47mm long.There is a tear approximately 19mm long that connects with the cut line.There is a vertical cut on the clear section approximately 112mm from the left side and is approximately 35mm long.When the contents in the pouch was removed a cut can be seen on the front.The front label is blocking the cut, so it can only be seen from the back.The cut is approximately 113mm from the left and is approximately 45mm long.All the cuts appear to line up.Microscopic examination revealed no additional damages.The balloon is still inside the hoop with the product mandrel and balloon protector in the manufactured position.Operations engineering also reviewed the cut in the device pouch.Because the cut does not go thru the front label they decided to peel the label to confirm if the line is an actual cut.After the label was peeled off light pressure was applied, and the cut can be seen separating.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a cut on the device pouch.
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