As per the report from the facility, the device was taken well above the labeled rated burst pressure.They stated that they took the balloon up to 30atm and it broke.The labeled rated burst pressure for this device is 20 atm.This device is approved for angioplasty of the femoral, renal and iliac arteries.They were using it for angioplasty of the pulmonary artery.This device is contraindicated for coronary arteries.The catheter was returned to numed for review.It was returned along with the sheath and the guidewire.The catheter was still in the introducer.The section of the shaft protruding from the distal end of the introducer is wrinkled.There is a detached section of the inner tubing on the guidewire.The balloon has torn laterally.The proximal end of the balloon is attached to the outer tubing.The distal end of the balloon has not been returned.The balloon was examined at 10x magnification.Nothing was observed that would have caused the balloon burst.The device history records were reviewed and no issues were identified.All devices that were distributed met the criteria for release and passed all inspection processes and procedures.There have been no other complaints with this catheter lot.A review of the balloon tubing used to manufacture this device was also performed.There were no other associated complaints with this lof of balloon tubing.A comparative device was pulled and tested for rated burst pressure.This device was the same balloon size and catalog number, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until failure.The balloon burst at 21 atm, which is above the labeled rated burst pressure of 20 atm.
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