(b)(4).Expiration date: unknown as lot # is unknown.Similar to device under 510(k) k073374.Mfr date unknown as lot # is unknown.Summary of investigational findings: the investigation is based on event description only, since no product was returned.It is not possible to investigate if the product is manufactured according to specifications, since no information regarding the product lot# was received.All the filter legs should be covered by the peelaway sheath.According to qc, there is 100% control on how the filter collapses in the sheath.According to complainant the peelaway sheath did not completely cover the filter legs while advancing the filter into the introducer.Based on the description of the event provided, it is possible that the filter legs scratched the inside of the introducer and thereby 2 legs protruded the introducer.It is also possible that a kink on the delivery system has occurred since the physician experienced a slight resistance, when the filter was advanced through the tuohy-borst.However, the exact root cause to the difficulties encountered is unknown since the product was not returned to assist the investigation.Cook medical will continue to monitor for similar events.
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