It was reported that during the implant procedure, the operator of the guide catheter was unable to advance the dilator into the valve at the end of the guide catheter.The guide catheter was removed from the operating field and when the dilator was forced through the valve, small plastic particles were noted to be pushed through the guide catheter and exited the distal tip.It was noted the valved appeared to not be patent and malformed during manufacturing.Another catheter from the same lot was utilized instead.No patient complications have been reported as a result of this event.
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