This report is being submitted as follow up no.1 to provide additional information in section b5, to update section d9, to update section h3, and to provide the completed investigation results.One 5fr 10cm glidesheath slender sheath and a lutonix balloon were returned for product evaluation.No other components were received for product evaluation.Visual inspection revealed that the sheath was folded in reverse and exited through the valve in the opposite direction.Dimensional testing was performed.The inner diameter of the tip of the sheath was measured to be 1.78 mm which was within the manufacturer specification of 1.69mm - 1.80 mm.The length of the lutonix balloon was measured to be 150 mm.Based on the returned device, the complaint can be confirmed for the sheath/catheter mechanical separation.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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