A savvy long balloon catheter (2.0x120mm l=150cm) failed to advance to the lesion.Then when the uninflated device was in the sheath upward, it was difficult and it could not be pulled out.Therefore, the surgeon cut the balloon delivery rod but still cannot be pulled out, so the sheath, balloon and the v18 guidewire were withdrawn together.Then used retrograde approach again, the same issue with the 4f cook micro sheath, v18 and another savvy long (2.0x120mm l=150cm).The second balloon catheter was not cut.Finally, withdrew the sheath and balloon together.Another savvy long balloon (lot# 4363012x) was used to cross the blood vessel.The patient did not experience any complications as a result of the failure with the device.However, the operation time was prolonged.The products will be returned for analysis.This was treatment to a left long segment occlusion of superficial femoral artery (sfa), the right side of the healthy limb with a retrograde approach.There was no anomalies noted during the prep of the devices.There was no damage noted to the box, pouch, hoop or balloon sleeves.There was no difficulty removing the balloon sleeves.There were no kinks noted on the device prior to use.Initially, the guidewire to the left femoral popliteal segment plain cannot be return to the true lumen then used the 4f cook micro sheath retrogressed, guidewire v18.The two device were not inflated/deflated, therefore inflation device and or other materials did not rupture.There were no kinks noted on the device during or after use.Force was required when using the device.The device did not separate or break into two or more pieces at any time during the procedure.It was noted that the user cut balloon delivery shaft because the balloon failed to delivered and failed to withdrawn, observed that the proximal of the balloon delivery shaft guidewire lumen was changed, director was doubt on the proximal of the balloon delivery shaft was damaged.
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