(b)(4).After the procedure the films were reviewed with the physician and volcano personal, the film revealed that the caudal retrieval tail was captured with the gooseneck snare but, was not seated within the 6f inner sheath.The 12f angled sheath appeared to move forward and caught on the tissue anchors causing the physician to exert excessive force in an attempt to try to re-sheath the crux vcf.During this manipulation, the snare released from the retrieval tails.After reviewing the venogram of the procedure, the angled 12f sheath appeared to angle into the crux vcf right at the point where the tissue anchors are attached to the helical wire frame.It appears as if the excessive force needed to re-sheath the filter caused the retrieval tail to straighten in the 12f angled sheath and the gooseneck snare slipped off the retrieval tail.The physician then removed the 12f sheath and replaced it with a 14f straight cook sheath (outer sheath) and used an en snare as well as the 6f sheath (inner sheath) that accompanies the en snare.The crux vcf was successfully retrieved.The physician inspected the crux vcf after retrieval and stated that the eptfe web and the framework were entirely intact.No surgical intervention was required and the pt was reported to be in stable condition.The filter although retrieval, was not returned to volcano for eval.The device involved was a limited market release product.It was explained to the physician that proper technique of capturing the retrieval tail and using a 6f sheath for the inner sheath.The physician stated that he was more than willing to use this sheath in the future.Volcano personnel visited the physician and demonstrated the retrieval technique using demo retrieval tools.
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