Investigation summary: with all the available information, boston scientific concludes that the reported event of incomplete seal was not confirmed as no leaks were identified in the syringe packaging and the visual and functional testing performed on the delivery device did not identify any irregularities that could affect the functionality.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device and syringe package were thoroughly analyzed.There were no leaks observed in the syringe packaging.The device was returned intact.The handle was in overall good physical condition.The external tubing had no kinks.Connecting cable was in good physical condition.The pins in the connector were clean and straight.The syringe luer and saline bag spike were in good condition.All buttons pressed and spring back with no issues.The backplate and top housing of the device were removed for internal visual inspection.The interior was in overall good physical condition.The returned device counter had shown it completed 3 treatment cycles.The retract/deploy functionality and the feel of the buttons were tested 5 times and worked as intended.Water pressure and temperatures during priming were nominal.The device completed the priming and pretreatment sequence with no issues.It was able to complete 5 full treatment cycles (deploy, treatment, and retract) with no issues.There were no leaks found in the device.The device passed functional testing.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.
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