The oad was returned to csi for analysis.The saline sheath had separated from the cartridge manifold and slid distally, partially over the crown.The saline sheath did not appear stretched, torn, or damaged at the separation site.Analysis of the manifold cross section confirmed that the saline sheath was fully seated and bonded within the manifold during the manufacturing assembly process.Bench testing revealed the oad sheath may have been pulled from the manifold without damage and still met the tensile requirement.It is unknown what amount of stress the bond was exposed to during the procedure.Blood was observed to be backed up into the saline sheath.The exact root cause of the saline sheath separation was unable to be determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).
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