Device evaluated by mfr: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink at the nose cone.Microscopic examination revealed no additional damages.The stent was deployed and did not return with the device.There is blood present on the device.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.Per product specification, a device to device interaction test was performed with a.035 guidewire.An amplatz super stiff.035 guidewire was used, and the guidewire could pass through the entire device.Some resistance was felt at the kink at the nose cone.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the froze on wire but did confirm some resistance at the kink.
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