H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream product that are cleared in the us.The pro code and 510k number for the lifestream product is identified in d2 and g5.H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation results: the sample was returned for evaluation.The investigation is confirmed for the reported device damaged prior to use issue.There was damage noted on one side of the stent.The stent was returned separate to the device and lodged within the stent guard.There was a yellow bodily substance residue noted on the stent.This is evidence that the stent had been handled by the health care provider.The definitive root cause for the reported device damage prior to use issue could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2022).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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