It was reported the advance 35 lp low profile balloon catheter leaked during an unspecified angioplasty procedure involving a (b)(6) year-old female patient with a history of "arterial peripheral disease.
" the balloon was properly introduced, with the distal tip reaching the injury site without complication.
Reportedly, the lesion being treated was a non-occlusive stenosis with moderate calcification.
As the physician began inflating the complaint device, the pressure on of the insufflator would not "hold", and slowly decreased.
When the physician withdrew the device from the patient, the balloon was leaking form the proximal end, near the connection point between the balloon material and the shaft.
A section of the device did not remain inside the patient¿s body.
The patient did not require any additional procedures due to this occurrence.
According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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