Exemption number e2016032.Manufacturer ref # (b)(4).Summary of investigational findings: investigation is based on description of event stating "the sheath ripped.They were not able to deploy the filter" and returned product.Only the sheath is returned.Three bends are noted - probably related to the subsequent packaging.However, in one of the bends ~35cm from the fitting, a penetration is noted.Based on this, it is assumed, that the penetration occurred due to a difficult approach in the patient.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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