It was reported that the procedure was performed to treat a severely calcified lesion in the left superficial femoral artery / popliteal artery.
The 5.
5 x 120 mm armada 18 dilatation catheter was prepared for use and no issues were noted.
The device was advanced into the patient anatomy.
The dilatation catheter balloon was inflated three times.
After the third inflation to 14 atmospheres, the balloon ruptured.
The rupture was large and the balloon separated from the device.
The device was removed without difficulty and all separated pieces were removed without additional intervention.
There was no adverse patient effect or clinically significant delay.
No additional information was provided.
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