Description of event according to initial reporter: "the filter was placed into the sheath, and physician felt resistance as she was advancing the filter thru the sheath.She pulled back and realized the filter was damaged.A new filter was opened and used to complete the procedure." patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Summary of investigational findings: investigation is based on event description and returned device.It was reported that resistance was felt, when advancing the filter through the sheath - the filter was pulled back and was found damaged.Only the femoral introducer with loaded celect-pt filter was returned.No observations to the introducer, but all secondary filter legs were misshapen and not aligned; one was pushed upwards, one was placed on the other side of the primary leg, and others had a too large diameter or were pushed sidewards.It was reported that the filter was pulled back and was found damaged, as if retracted through the check-flo valve and said maneuver probably caused the damages to the filter; according to ifu repositioning of the preexpanded filter is possibly only by advancing the filter, as retracting the filter could damage the secondary filter 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.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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