The catheter (sn: (b)(4)) was returned to ekos on 7/7/17 for evaluation.The catheter evaluation confirmed the ultrasound core was fractured and the fracture occurred at the shaft to treatment zone joint.Examination of the ultrasound core shows indications of a prior kink in the fracture region, and some bending on internal wires.During follow up, ekos qa was informed that the patient anatomy was not tortuous and free of any graft.A definitive root cause could not be identified.Ekosonic endovascular device instructions for use states: do not deform or kink the ultrasound core during delivery into the infusion catheter.If the ultrasound core is kinked at any time, do not attempt to use it, as kinking may lead to degraded performance or fracture during use.Review of the manufacturing records indicates that the product was manufactured according to specification following all applicable procedures and the finished device met all acceptance criteria prior to release.
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