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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, coronary, atherectomy
Product CodeMCX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
8 8 10 5 12 10 13 18 25 8

Device Problems
Entrapment of device or device component 265
No Known Device Problem 234
Fracture 189
Difficult to remove 166
Unknown (for use when the device problem is not known) 144
Wire(s), breakage of 112
Device or device component damaged by another device 93
Device operates differently than expected 74
Detachment of device component 70
No display or display failure 56
Detachment of device or device component 49
Device, or device fragments remain in patient 45
Balloon rupture 39
Foreign material present in device 39
Break 36
Kinked 36
Device damaged prior to use 31
Use of Device Issue 21
Failure to advance 19
Other (for use when an appropriate device code cannot be identified) 15
Tip breakage 15
No Information 14
Leak 13
Fluid leak 12
Physical resistance 12
Foreign material 11
Difficult to insert 11
Sticking 11
Stretched 10
Difficult to advance 10
Tears, rips, holes in device, device material 9
Material perforation 9
Device Issue 9
Malfunction 8
Hole in material 8
Unstable 8
Torn material 8
Defective component 7
Material separation 7
Unintended movement 6
Device or device fragments location unknown 6
Material fragmentation 5
Air leak 5
Disconnection 4
Difficult to position 4
Split 4
Aspiration issue 4
Device displays error message 3
Device, removal of (non-implant) 3
Device Difficult to Setup or Prepare 3
Decrease in pressure 3
Device stops intermittently 3
Device remains activated 3
Unsealed device packaging 3
Delivered as unsterile product 2
Loose or intermittent connection 2
Dislodged 2
Dissection 2
Flaked 2
Blockage within device or device component 2
Bent 2
Declotting 2
Source, detachment from 2
Shaft break 2
High Readings 2
Tear, rip or hole in device packaging 2
Unraveled material 2
Material deformation 2
Material twisted 2
No flow 1
Gas leak 1
Improper device output 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Balloon pinhole 1
Connection issue 1
Pressure issue 1
Device inoperable 1
Failure to select signal 1
Material puncture 1
Failure to power-up 1
Sterility 1
Deflation issue 1
Bubble(s) 1
Burn of device or device component 1
Bleed back 1
Failure, intermittent 1
Erratic display 1
Incorrect display 1
Melted 1
Mislabeled 1
Material frayed 1
Failure to flush 1
Occlusion within device 1
Output energy incorrect 1
Output above specifications 1
Peeled 1
Total Device Problems 2042

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 2 0
Class II 1 0 0 0 0 0 0 0 0 0
Class III 1 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Nov-13-2015
2 Cardiovascular Systems, Inc. I Mar-20-2015
3 Cardiovascular Systems, Inc. III Feb-26-2014
4 Possis Medical, Inc III Jun-21-2007
5 St Jude Medical CRMD II Jun-14-2007

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