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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 2017
8 8 10 5 12 10 13 18 25 16 5

Device Problems
Entrapment of device or device component 388
No Known Device Problem 334
Fracture 257
Difficult to remove 175
Device or device component damaged by another device 151
Unknown (for use when the device problem is not known) 144
Wire(s), breakage of 112
Device operates differently than expected 103
Detachment of device component 103
No display or display failure 72
Detachment of device or device component 55
Device, or device fragments remain in patient 45
Break 44
Kinked 42
Foreign material present in device 42
Balloon rupture 39
Device damaged prior to use 36
Aspiration issue 27
Device displays error message 26
Failure to advance 24
Use of Device Issue 21
Sticking 18
Fluid leak 17
Leak 16
Tip breakage 15
Other (for use when an appropriate device code cannot be identified) 15
Material separation 14
No Information 14
Physical resistance 12
Defective component 12
Stretched 12
Hole in material 12
Difficult to insert 12
Foreign material 11
Difficult to advance 10
Device Issue 9
Tears, rips, holes in device, device material 9
Material perforation 9
Malfunction 8
Torn material 8
Unstable 8
Unintended movement 7
Device or device fragments location unknown 6
Device stops intermittently 5
Material fragmentation 5
Air leak 5
Bleed back 4
Disconnection 4
Device remains activated 4
Difficult to position 4
Split 4
Device, removal of (non-implant) 3
Unsealed device packaging 3
Delivered as unsterile product 3
Device Difficult to Setup or Prepare 3
Decrease in pressure 3
Contamination during use 3
Declotting 2
Dislodged 2
Blockage within device or device component 2
Bent 2
Burn of device or device component 2
Dissection 2
Flaked 2
Loose or intermittent connection 2
Overheating of device or device component 2
Shaft break 2
Source, detachment from 2
Failure to deliver 2
Unraveled material 2
High Readings 2
Tear, rip or hole in device packaging 2
Material deformation 2
Material twisted 2
No flow 1
Gas leak 1
Improper device output 1
Inappropriate or unexpected reset 1
Pressure issue 1
Noise, Audible 1
Balloon pinhole 1
Connection issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Sterility 1
Device inoperable 1
Failure to select signal 1
Material puncture 1
Occlusion within device 1
Output energy incorrect 1
Output above specifications 1
Peeled 1
Failure to power-up 1
Melted 1
Mislabeled 1
Excess flow or overinfusion 1
Failure, intermittent 1
Material frayed 1
Failure to flush 1
Bubble(s) 1
Total Device Problems 2607

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 2 0 0
Class II 1 0 0 0 0 0 0 0 0 0 1
Class III 1 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-03-2017
2 Boston Scientific Corporation I Nov-13-2015
3 Cardiovascular Systems, Inc. I Mar-20-2015
4 Cardiovascular Systems, Inc. III Feb-26-2014
5 Possis Medical, Inc III Jun-21-2007
6 St Jude Medical CRMD II Jun-14-2007

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