D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device may not have been prepped correctly.After the case it was questioned if the tech had prepped the device properly.Further details were not provided.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to the as reported 'flow diverter stent difficult/unable to capture into micro-catheter', 'stent difficult/unable to advance or pullback through catheter' for this complaint.
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