The catheter was returned in a plastic bag.The balloon has a lateral tear and also a circumferential tear.The distal end of the balloon , along with the entire length of the guidewire tubing is detached.The guidewire is still in the guidewire tubing.The guidewire tubing has been stretched over the wire.The detached portion of the balloon has been partially folded under itself.This appears to have benn caused by the introducer.A comparative catheter of the same catalog number was tested for rated burst pressure.The balloon was immersed in a body temperature water bath and inflated until it failed.There was a longitudinal tear at 8 atm, which is double the labeled rated burst pressure of 4 atm.It is likely that the calcium spicule caused the balloon burst and then the detachment occurred when the physician attempted to pull the balloon back through the introducer sheath.The instructions for use has the following precaution regarding this issue: "if resistance is felt upon removal, then the balloon and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.".
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