Same case as mfr# 2134265-2014-02204.Reportable based on device analysis completed on (b)(4)2014.It was reported that resistance was encountered when moving this device.The 80% stenosed target lesion was located at the mildly tortuous and mildly calcified right external iliac artery.The vascular access was obtained from the side of the lesion with retrograde approach.During the dilatation of the lower limb vessel, v-18¿ control wire¿ guide wire was able to cross the lesion, then intravascular ultrasound (ivus) was performed using an atlantis¿ 018 imaging catheter.Stent sizing was done during ivus.While removing the imaging catheter to perform stenting, resistance was encountered near a hemostasis valve of the sheath.The distal tip of the imaging catheter seemed to come into contact with the valve.The device was removed by flushing it.However, the distal tip was noticed to be detached.The detached part was caught on a portion of the guide wire outside the patient's body.They could not determine if the detached part was stretched or not.No fragment was found in the body.The physician thought that the detachment occurred outside the patient's body.A renegade micro catheter was also used during the procedure and resistance was encountered while advancing the guide wire through it.The physician alleged that resistance was also encountered between the micro catheter and the imaging catheter and between the guide wire and the imaging catheter.The procedure was completed with another of the same imaging catheter.No patient complications were reported and the patient's condition is good.However, device analysis revealed a foreign material (fm)on the proximal end of the catheter and under the strain relief.
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