Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The aurous centimeter vessel sizing catheter was not returned for evaluation.However, images were provided that confirmed the unidentified foreign matter within the primary device packaging.A document-based investigation was performed.Review of the device history record shows no nonconforming events.In addition, there were no other reported complaints for this lot number.Based on the information provided, examination of the images provided, and the results of our investigation; the root cause has been attributed to manufacturing.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
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