(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.The incident information was reviewed; however, it was not possible to perform a thorough analysis on the product because it was not returned to abbott vascular for investigation.A review of the lot history record and complaint history of the reported part and lot could not be conducted because the part and lot numbers were not provided.The investigation determined the reported balloon rupture and separation appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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