The device was returned to boston scientific for analysis.Visual inspection noted blood on the handle, shaft, cap, and inside towards the valve seal.Microscopic visual examination noted a tear on the valve seal where it intersects with the outer slit.The device passed hemostasis at 5.5 psi pressurization with saline, and aspiration with 10 cc and 60 cc syringes at various flowrates.The device did not pass both hemostasis and aspiration testing while the polarx test catheter was inserted into the sheath and tipped at slight angles.Air pressure testing was performed to identify the location of any potential leaks.The device was gently pressurized at the flushing line luer fitting while plugging the distal tip of the catheter; the measurements were within the acceptable range and no air bubbles were observed.Laboratory analysis confirmed that a tear in the hemostatic valve led to the saline leaking observed during the procedure.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.There is no evidence this device was used in a manner inconsistent with the labeled indications.
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