The device was not returned to numed for review, the complaint could not be confirmed.The user facility would not release the product.This device was not used on a patient.According to the user facility, the balloon ruptured during preparation.A review of the device history records was performed and no issues were noted.There are no other complaints associated with this catheter lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material that was used to manufacture the balloons.As per the instructions for use, an inflation device with pressure gauge should be used on the device to monitor pressure.In this case, an inflation device with pressure gauge was not used during the preparation process.A syringe was used which does not allow you to monitor pressure being added to the balloon, so it is unknown as to what pressure the balloon was taken to, and what pressure the balloon burst.A comparative catheter was pulled and tested for rated burst pressure.It was the same catalog number/size as the complaint catheter, but was from a different lot number.The balloon was immersed in a body temperature bath and inflated until it burst.The catheter did not burst until 3.5 atm, which is well above the labeled rated burst pressure of 2.0 atm.
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