Upon receipt at our post market quality assurance laboratory the sheath was first visually inspected which found nothing abnormal.Next, the sheath was put through procedural testing by replicating aspiration.The sheath failed this aspiration test as air was visible in the flushing line each time the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was not able to maintain pressure even when there was nothing across the valve.Finally, they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a gross leak of the hemostatic valve.With all the available information boston scientific concludes the allegation of "air observed in the sheath" is confirmed.The kind of leak seen in the testing can lead to air being observed in the sheath during use.
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