Physician was attempting to use the evercross pta balloon during procedure to treat superficial femoral artery.
A 6fr sheath and 0.
035'' guidewire were used.
There was no damage noted to packaging, i.
E.
Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.
The device was prepped per ifu with no issues.
It was reported that the balloon burst under low pressure 5-6 atm.
The balloon was dislocated completely from the shaft.
The balloon couldn't be removed from the vessel, so it had to be trapped with a covered stent in the distal iliac artery.
Physician stated that 'normally if i see that a balloon is destroyed, the covering is on the balloon, but in this case it was away'.
No patient injury.
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