A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported material separation appears to be related to circumstances of the procedure, as it is likely the device interacted with accessory devices during advancement resulting in the reported material separation.Manipulation of the device during advancement likely contributed to the noted bent, flared and stretched stent struts, kinked/wrinkled inner/outer member and bent skive.Further manipulation of the device during retraction likely contributed to the noted stretched and torn guide wire exit notch.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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