(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: investigation of returned device confirms that sheath is kinked and perforated.Filter appears fine.Under normal conditions the sheath is strong enough to accomplish the procedure, but it is seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy.If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.However without image it is not possible to confirm if patient had tortuous anatomy.Therefore it is concluded that the difficulty encountered while patient was unsteady is most likely the root cause to this event.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Description of event according to initial reporter: the patient kept moving during the procedure and it was not possible to keep the patient still.A 8.5fr.Sheath which was included in the gunther set was inserted from the right internal jugular vein, then filter introducer was inserted into the sheath and peel-away sheath was peeled off at the point when the filter was advanced into the sheath.Right after that, the physician encountered strong resistance, and the filter became unable to advance or retract.Since the introducer could not be pushed to advance the filter anymore, the introducer was pulled hard, then the filter was withdrawn out from the sheath.However, since the filter could not be even inserted into the sheath then, another manufacturer's device was used instead and placed with no problem.Patient outcome: there has been no adverse effects to the patient.
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