As reported, the balloon of a saber rx 4mm 15cm 155 ruptured after passing the nominal pressure 8 atm, it ruptured at approximately 10 to 12 atm; therefore, it was replaced with a new saberx (4mm*10cm) and it could be inflated 14 atm and the case was completed.
There was no reported injury to the patient.
The product was stored properly according to the instructions for use (ifu).
There was no difficulty removing the device from the hoop.
There was no difficulty noted while removing the protective balloon cover, stylet, or any of the sterile packaging components.
There were no kinks or other damages noted on the device prior to inserting into the patient.
The device was prepped per the ifu and was able to maintain negative pressure.
The lesion was the left superficial femoral artery, popliteal artery to back-knee with stenosis and occlusion.
An approach was made from the right femoral artery with a non-cordis 6f guiding sheath.
A non-cordis.
018 guidewire crossed the lesion.
The lesion was noted to have moderate to severe calcification.
The vessel had moderate tortuosity.
The lesion had a 80%-100% stenosis.
The device was being used to treat a chronic total occlusion (cto).
A saberx (3mm*4cm) was inflated at the superficial femoral artery to the popliteal artery.
After that, the saber rx 4mm 15cm 155 was used.
It crossed the lesion and inflated the ruptured.
The non-cordis inflation device was filled with visipaque.
The contrast/saline ratio was unknown.
The inflation device was used successfully with other devices during the case.
A y-connector was used for inserting the balloon catheter.
The balloon catheter was never in an acute bend and was never kinked while being used.
The device was removed without any issues.
The device was discarded and will not be returned.
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