Description of event according to initial reporter: the user felt resistance during the process of advancing the delivery system, then removed the device and found the sheath was punctured by one of the primary legs.The user changed to another new device to completed this procedure successfully.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer ref# (b)(4).Summary of investigational findings: the investigation is based on the returned device and the information provided.It was reported that a primary leg pricked the sheath and that a new device was required.The complete uni device was returned and every component was slightly curved.The filter stuck inside the introducer sheath with two primary filter legs penetrating from the sheath wall in a kink 43-44cm from the hub and distal to the penetrations more kinks were noted.In the jugular introducer a dent was noted in the most distal tip and the release mechanism did not work, when release button was pressed.However, after soaked in water the grasping hook moved freely inside the introducer, but was found straightened and out of shape.Only very limited information was provided and under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and following, the filter legs may be prone to exceed the sheath wall, if advanced through a kinked sheath.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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