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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, balloon, transcervical
Product CodeMKN
Device Class 3

Device Problems
Balloon leak(s) 100
Other (for use when an appropriate device code cannot be identified) 75
Decrease in pressure 40
Material perforation 32
Burn of device or device component 28
Balloon burst 24
Unknown (for use when the device problem is not known) 17
Device displays error message 3
Increase in pressure 2
Failure to prime 1
Probe failure 1
Failure to service 1
Component(s), overheating of 1
Heat, failure to 1
Premature explantation 1
Device Issue 1
Defective item 1
Total Device Problems 329

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