(b)(4).Catalog number: unknown but referred to as a cook celect filter.(b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.
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Exemption number e2016032.(b)(4).Summary of investigational findings: the provided images (venogram and x-ray) demonstrate a mal-deployed celect filter located in the caudal ivc/right iliac vein.The primary filter feets are deployed within the central portion of the right common iliac vein.All eight secondary legs are clustered near the apex of the filter which demonstrates frank perforation through the wall of the ivc.The description of event states, that the physician tried to re-sheath the secondary struts, however the approach (fem/jug) are not specified.Given that the venographic image does not demonstrate a catheter from a jugular approach, a femoral approach is assumed.The ifu states ¿the filter may be repositioned only by advancing the filter; retracting the filter could damage the secondary legs or caval wall.¿ as the operator attempted to retract the ivc filter, this in turn created significant distortion of the secondary legs resulting in the clustered appearance seen on the imaging.Furthermore, the physician then attempted to advance the filter in the ivc, resulting in perforation of the filter hook and proximal margin of the filter through the ivc wall.The filter is meant only to be advanced cranially in the straight portion of the ivc, not at the junction of the iliac veins and ivc and not in the setting of significant damage to the secondary arms which help self-center the filter in the ivc.Finally, the filter demonstrates significant tilt.According to the imaging review, all of the complications associated with this deployment are directly related to the operator and are of no fault of the filter design, patient¿s anatomy or potential underlying disease state.This filter should not have been left in this configuration, and will only become more difficult to remove with time.Lot# and rpn are unknown but 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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