Description of event according to initial reporter: "physician got access into right vein, he used the dilator, inserted the sheath removed the inter dilator, inserted the filter partway in, we did not click the back end together, he decided to re adjust his position and do another venogram, he removed the filter and the filter was damaged in the process.He has removed the filter before without any problems." patient outcome: unknown.
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Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings; investigation is based on event description and returned product.The femoral introducer with loaded filter, the sheath, and the long dilator were returned.Investigation found the filter severely damaged with all filter legs curled and bending upwards in the direction of the clip bushing.These findings combined with the report stating that attempts were made to reposition the filter and that "the filter was damaged in this process" clearly indicate that attempts were made to move the pre-expanded filter downwards.According to the ifu, repositioning is possible only by advancing the filter; retracting the filter could damage the secondary legs or the caval wall.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.
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