The following were reviewed as part of this investigation:patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a split microintroducer is confirmed but the exact cause remains unknown.One 4 fr excaliber microintroducer was returned for evaluation.The product label indicates lot: redx2309.Blood residue was present throughout the sheath and needle.The tabs and the proximal end of the sheath were observed to split and peeled.Microscopic observation of the tabs revealed one of the sections to be fully split with the opposite section being partially split.The sheath splitting was observed to have propagated downwards.Based on the evidence of use and partial split of the tabs and sheath, possible contributing factors include resistance during advancement leading to unintentional splitting and damage during storage or handling.Since the device was found to be partially split, the complaint is confirmed but the exact factors leading to the issue could not be determined.A review of the manufacturing records did not reveal any evidence to suggest that a manufacturing-related root cause contributed to the alleged event.A lot history review (lhr) of redx2309 showed no other similar product complaint(s) from this lot number.
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