The customer complained of particles being inside sterile field of packaging of multiple 9f.098 str 55cm guide catheters.The integrity of the sterile pouch was not compromised.The actual product was not damaged.The devices were not used in a patient.There was no damage to the outer product box.No other information was reported.The devices were returned for analysis.212 sterile units, corresponding to cat.No.598943p, (gc 9f.098 str 55cm) lot no.17807995, were received for analysis.Particles (angel hair/slivers) were noted in the sterile packaging and remained attached to the mounting card tabs.A review of the manufacturing documentation associated with lot 17807995 was performed and a risk assessment has been opened to further investigate this issue.The event reported by the customer as ¿packaging/pouch/box - foreign material - in sterile package¿ was confirmed, due to frays of cardboard (angel hair/slivers) attached to the mounting cards tabs, as well as loose angel hair/slivers being detected after removing the device from the packaging, being confirmed.This material is part of the mounting card material and were not cleanly cut.The inner pouches were fully reviewed.According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.
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