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Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
The incorrect device is contained in the labeled package.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.