The balloon burst was confirmed.Two comparative catheters from different lots were pulled and tested for rated burst pressure.The labeled rbp for this device is 5.0 atm.The first comparative catheter was inflated until failure.The device was taken to rbp (5.0 atms) with no issues.It was then over inflated to 11.5 atms, which is greater than double the rbp, where it burst longitudinally.The second comparative catheter was also inflated until failure.The device was taken to rbp (5.0 atms) with no issues.It was then over inflated to 11.0 atms, which is also greater than double the rbp, where it burst longitudinally.It is unknown what caused the balloon to burst.
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