The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached guidewire is confirmed and was determined to be use related.One 18 g powerglide pro device was returned for evaluation.An initial visual observation showed use residues throughout the returned sample.The sample was returned with the catheter and plug separate from the housing and a detached segment of the guidewire.This segment which was observed to be partly unraveled toward its proximal half and kinked near its distal end.A microscopic observation revealed the weld tip of the guidewire was present and intact.The core wire of the guidewire could be seen protruding from the distal tip of the needle within the safety mechanism.The break site of the core wire on the detached segment of the guidewire was observed to be tapered with a mostly flat and granular surface.The fracture surface of the coiled wire was also observed to be flat and granular.The proximal end of the guidewire was observed to be properly aligned within the coupler and attached to the needle housing.The features observed on the break surfaces of the guidewire are indicative of tensile (pulling) failure, which the event description, as well as the usage residues observed on the returned sample, suggest the damage occurred during use.A lot history review (lhr) of redv3450 showed no other similar product complaint(s) from this lot number.
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It was reported that when placing the catheter, the nurse realized that the guidewire was disconnected from the delivery device when it was removed.He removed the catheter and found that the guide wire was still attached to it, so he was able to successfully extract both.On 4/14/2020- returned wire is frayed and kinked.
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