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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on review of the similar incidents, there is no indication of a lot specific issue.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the challenging anatomical conditions resulted in the reported failure to advance and difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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