Investigation - evaluation : a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One advance 14 lp low profile balloon catheter was returned in opened, unused condition.A single clear fiber was visible on the surface of the balloon.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control documentation, "inspect all package seals (end seals, side seals, and chevron seal if applicable).Examine each seal for defects, foreign matter (dirt, hair, paper, fuzz, etc.).Ensure each seal is completely solid, smooth, and free from wrinkles.Seals must not be in the thumb notch.Product or inner pouch must not be caught in the seal.Examine entire package for defects.Product must be free of any visible cuts, holes, or foreign matter (dirt, hair, paper, fuzz, etc.)." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the foreign matter was determined to be related to manufacturing.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
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