Exemption number e2019001.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.In this case, it is possible that the device was inadvertently mishandled and/or removed at an angle during unpacking at the account resulting in the reported separation; however, since the device was not returned for analysis and limited information was provided, a conclusive cause cannot be determined.The investigation was unable to determine a conclusive cause for the reported separation.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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