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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