Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the sheath had a split and that the filter could not be inserted.Another device was used.The jugular introducer with protection sheath and the dilator inside the introducer sheath were returned.The red safety button was pressed, ie the system was unlocked.The protection sheath was damaged as if twisted 55mm from the distal end and had a dent 39.5mm from same.In the introducer sheath a penetration, likely caused by a primary filter leg, was noted 0-8.5mm from the hub and dents were noted in the tip of the introducer sheath.After removing the dilator from the introducer sheath attempts were made to advance the jugular introducer through the sheath, but resistance was met immediately after the hub, ie in the area of the penetration.The exact reason why the jugular introducer could not be advanced through the sheath cannot be determined.Under normal conditions the sheath will be strong enough to accomplish the procedure, but the sheath may kink if advanced through tortuous anatomy and the filter legs may be prone to exceed the sheath wall if advanced through a kinked sheath.According to the instructions for used excessive force should not be exerted to advance the filter.There are adequate controls in place to ensure that this type of device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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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