It was intended to use a sprinter otw balloon catheter to treat a severely tortuous, severely calcified distal lesion exhibiting 95% stenosis in a peripheral artery (below the knee near the foot).There was no damage noted to packaging or issues removing the device from the hoop/tray.No stylet removal difficulties.The device was inspected and prepped with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device however excessive force was not used.The device was not kinked and re-straightened during use.It is reported that upon inflation, the balloon burst at 10 atm.There was a sudden drop in pressure from inflation device.The balloon was not repositioned before burst.The balloon then separated from the shaft with the single marker intact and when the physician removed the system from the patient the detached portion remained in the very distal tibial artery.An attempt was made to snare with a loop snare however the snare could not get all the way down to the foot.A surgical consult decided that it was not an option to cut down and remove the balloon.The detached portion of the device remains in the patient.
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