Manufacturers ref# (b)(4).Summary of investigational findings: the hook of the filter perforated the introducer sheath.No additional details could be provided for the investigation, however, no adverse effects on the patient has been reported due to this occurrence.No product was returned for evaluation and no photos are available.Ifu states that excessive force should not be exerted.However, it is not clear in the event description whether the patient had a tortuous anatomy, if the introducer sheath kinked or if the user felt difficulty in advancing the introducer with the filter through the sheath.Due the insufficient information in the event description, the likely cause for the reported event cannot be established.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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