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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 278
No Known Device Problem 244
Fracture 204
Difficult to remove 167
Unknown (for use when the device problem is not known) 144
Wire(s), breakage of 112
Device or device component damaged by another device 100
Device operates differently than expected 79
Detachment of device component 73
No display or display failure 62
Detachment of device or device component 49
Device, or device fragments remain in patient 45
Balloon rupture 39
Foreign material present in device 39
Kinked 38
Break 37
Device damaged prior to use 33
Use of Device Issue 21
Failure to advance 19
Other (for use when an appropriate device code cannot be identified) 15
Tip breakage 15
Fluid leak 14
No Information 14
Leak 13
Physical resistance 12
Foreign material 11
Sticking 11
Difficult to insert 11
Stretched 10
Difficult to advance 10
Tears, rips, holes in device, device material 9
Material perforation 9
Device Issue 9
Hole in material 9
Material separation 9
Defective component 8
Unstable 8
Malfunction 8
Torn material 8
Unintended movement 6
Device or device fragments location unknown 6
Material fragmentation 5
Air leak 5
Disconnection 4
Device stops intermittently 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
Unsealed device packaging 3
Device remains activated 3
Source, detachment from 2
Shaft break 2
Unraveled material 2
Tear, rip or hole in device packaging 2
Dislodged 2
Declotting 2
Burn of device or device component 2
Dissection 2
Blockage within device or device component 2
Bent 2
Flaked 2
Loose or intermittent connection 2
Delivered as unsterile product 2
High Readings 2
Material deformation 2
Material twisted 2
No flow 1
Gas leak 1
Improper device output 1
Pressure issue 1
Balloon pinhole 1
Connection issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Occlusion within device 1
Output energy incorrect 1
Output above specifications 1
Melted 1
Mislabeled 1
Material frayed 1
Failure to flush 1
Failure, intermittent 1
Bleed back 1
Bubble(s) 1
Contamination during use 1
Incorrect display 1
Deflation issue 1
Erratic display 1
Device inoperable 1
Failure to select signal 1
Sterility 1
Peeled 1
Material puncture 1
Failure to power-up 1
Total Device Problems 2116

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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