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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 11

Device Problems
Entrapment of device or device component 431
No Known Device Problem 374
Fracture 281
Device or device component damaged by another device 180
Difficult to remove 177
Unknown (for use when the device problem is not known) 144
Device operates differently than expected 117
Wire(s), breakage of 112
Detachment of device component 109
No display or display failure 82
Detachment of device or device component 57
Break 49
Device, or device fragments remain in patient 45
Kinked 44
Foreign material present in device 42
Balloon rupture 39
Device damaged prior to use 36
Device displays error message 32
Aspiration issue 32
Failure to advance 30
Sticking 22
Use of Device Issue 21
Fluid leak 21
Leak 16
Other (for use when an appropriate device code cannot be identified) 15
Tip breakage 15
Material separation 14
Defective component 14
No Information 14
Physical resistance 13
Difficult to insert 13
Stretched 12
Hole in material 12
Foreign material 11
Difficult to advance 10
Torn material 10
Material perforation 9
Device Issue 9
Tears, rips, holes in device, device material 9
Unstable 8
Malfunction 8
Unintended movement 7
Device or device fragments location unknown 6
Air leak 6
Material fragmentation 5
Device stops intermittently 5
Device remains activated 4
Difficult to position 4
Bleed back 4
Disconnection 4
Split 4
Device, removal of (non-implant) 3
Tear, rip or hole in device packaging 3
Contamination during use 3
Device Difficult to Setup or Prepare 3
Decrease in pressure 3
Overheating of device or device component 3
Unsealed device packaging 3
Delivered as unsterile product 3
Material rupture 2
Source, detachment from 2
Shaft break 2
Unraveled material 2
Declotting 2
Dislodged 2
Burn of device or device component 2
Charred 2
Blockage within device or device component 2
Bent 2
Loose or intermittent connection 2
Dissection 2
Flaked 2
High Readings 2
Failure to deliver 2
Material deformation 2
Material twisted 2
Mechanical jam 1
No flow 1
Pressure issue 1
Pumping issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Gas leak 1
Improper device output 1
Inappropriate or unexpected reset 1
Balloon pinhole 1
Connection issue 1
Noise, Audible 1
Failure to flush 1
Incorrect display 1
Failure, intermittent 1
Melted 1
Migration of device or device component 1
Mislabeled 1
Material frayed 1
Excess flow or overinfusion 1
Defective Alarm 1
Bubble(s) 1
Erratic display 1
Deflation issue 1
Total Device Problems 2820

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 2
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 II May-20-2017
4 Cardiovascular Systems, Inc. I Mar-20-2015
5 Cardiovascular Systems, Inc. III Feb-26-2014
6 Possis Medical, Inc III Jun-21-2007
7 St Jude Medical CRMD II Jun-14-2007

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