(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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(b)(4).Unique device identification (udi): unknown.The udi is unknown because the part number and lot number was not provided.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported stent damage from the armada 35 appears to be due to operational context.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the devic.
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