Date of event, relevant tests/laboratory data: dates are estimated.The udi# is unknown due to the part/lot number was not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effect of dissection is listed in the pressurewire instruction for use as a known potential complication which may be encountered during all catheterization procedures.In this case, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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