Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.It was reported that a fiberoscopy after a difficult intubation found 2 blue pieces of plastic in the patient's airways.One of the pieces was removed and no harm to the patient was reported.Despite several attempts to obtain additional information it is unknown if the catheter was used with a double lumen tube and/or if the second piece of blue plastic was removed.The frova catheter and the small piece of catheter material were returned.An investigation of the catheter revealed a flaking of the material distal to the side-hole and a scratch/damage in the catheter opposite to the flaking.Unfortunately, it was not reported if the catheter was used with a single lumen tube and the type of the tube is unknown, too.Therefore, it is unknown if the tube may have had a sharp edge and/or if the angle of introduction or removal over the frova has potentially caused a shaving of frova material to occur.The material is radiopaque extruded polyethylene and the material characteristics do not suggest that flaking would occur, but if it were to encounter a rough edge it may be possible.There is 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.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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