Reportable based on analysis completed on (b)(4) 2014.It was reported that during a filter placement procedure, the cannula became kinked.Vascular access was obtained via the femoral artery.This 12 fr greenfield¿ filter was selected and was advanced into an unspecified lesion with no issues noted.It was placed well superior to the markers, the dilators and the greenfield filter worked efficiently.The dilator catheter that goes up the wire passed with no problem.When the trocar of the catheter was taken out and the filter device was placed into the lumen of the cannula, it advanced maybe 40cm and then would not go any further.Under fluoroscopy they saw a kink in the cannula (the introducer cannula) and filter itself would not pass further than that and this happened on both pieces of equipment.It was noted that it happened in the exact same way both times during the same case and same patient.They withdrew and placed a greenfield filter in the jugular vein approach and both femoral kits were defective.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that no filter was present in the capsule.
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