Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter with no other devices.The shaft was examined.The hypotube was completely separated 76.5cm from the hub.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.There were numerous kinks throughout the hypotube.The tip was damaged.The guidewire exit notch was damaged, the damage is consistent with interaction with the product mandrel or guidewire.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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