[47371]
It was reported two balloons ruptured during a pulmonary homograft valvuloplasty of a calcified lesion. Physician chose not to use another balloon catheter. No pt complications were involved. These devices were destroyed by the uf. Therefore, no failure analsis will be available. Balloon rupture or balloon leakage is an anticipated event of valvuloplasty which has been associated with overpressurization or use in a calcified lesion. Graft stenosis (anastomotic and non-anastomotic) tend to be more difficult to open and usually require much higher pressures for effective dilatation than do native vessels. Access to bypass grafts for angioplasty may also contribute to balloon failure. Post-op scarring and/or lesions in both the proximal and distal aspects of the graft may necessitate balloon manipulation through plaque or calcification. These devices were used in a pulmonary valvuloplasty which is a non-indicated procedure. It was also indicated that the lesion was calcified. Therefore, co does not attribute this event to the devices. However, without evaluating the devices co cannot determine the exact cause for this event. Directions for use state: "due to the thin wall thickness of the balloon, balloon catheters should not be used for procedures involving highly calcified lesions or synthetic vascular grafts... If loss of pressure within the balloon occurs during inflation or if balloon ruptures during dilatation, immediately discontinue the procedure. Deflate the balloon. Do not reinflate and remove carefully... Co's balloon dilatation catheters are recommended for percutaneous transluminal angioplasty of narrow segments in the iliac and femoral arteries in the peripheral vascular... Co's catheters are not indicated for use in coronary arteries nor in the neurovasculature. "
Patient Sequence No: 1, Text Type: D, B5