The sections have been updated on this report.As reported, during the insertion of a trapease vena cava filter, when advancing the pusher rod the black dot was missing and the filter was deployed more proximal than desired.Multiple attempts to gather additional information have been made and have been unsuccessful.If additional information is received, the file will be updated accordingly.The product was not returned for analysis.A device history record (dhr) review of lot 17472122 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported filter- inaccurate placement and obturator- missing component-marker band could not be confirmed as the device was not returned for analysis.Without procedural films for review, the reported events could not be confirmed and the exact cause could not be determined.Per the instructions for use (ifu) advance the filter until the marker on the obturator is positioned at the sheath introducer hemostasis valve.This indicates that the filter is at the distal tip of the sheath introducer but still fully within the sheath introducer.It is standard practice for interventional procedures to examine the device prior to use.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.
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