Device evaluated by manufacturer - the device has a kink at the distal section while in the neutral position at 14mm from the tip.Rings #1 and #2 have broken adhesive and fluids under them.The right curve is placed in the template shaded are, but the left curve is not placed in the template shaded area, the device failed the dimensional test.The handle was opened, and no issues were detected in that section.The device was dissected and the guide coil was inspected finding no issues on it.The distal section was dissected finding the center support kinked at 14mm.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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