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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 22

Device Problems
Entrapment of device or device component 495
No Known Device Problem 437
Fracture 310
Device or device component damaged by another device 215
Difficult to remove 186
Unknown (for use when the device problem is not known) 144
Device operates differently than expected 136
Detachment of device component 127
Wire(s), breakage of 112
No display or display failure 90
Detachment of device or device component 62
Break 54
Kinked 50
Device, or device fragments remain in patient 45
Foreign material present in device 43
Aspiration issue 41
Device displays error message 41
Device damaged prior to use 39
Balloon rupture 39
Failure to advance 33
Sticking 26
Fluid leak 22
Material separation 21
Use of Device Issue 21
Leak 16
Tip breakage 15
Difficult to insert 15
Other (for use when an appropriate device code cannot be identified) 15
Defective component 15
Physical resistance 14
No Information 14
Torn material 13
Hole in material 13
Stretched 12
Foreign material 11
Difficult to advance 10
Device Issue 9
Material perforation 9
Tears, rips, holes in device, device material 9
Unstable 8
Air leak 8
Malfunction 8
Unintended movement 7
Device or device fragments location unknown 6
Material fragmentation 5
Device stops intermittently 5
Unsealed device packaging 4
Device remains activated 4
Decrease in pressure 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
Material deformation 3
Burn of device or device component 3
Contamination during use 3
Bent 3
Overheating of device or device component 3
Device Difficult to Setup or Prepare 3
Delivered as unsterile product 3
Unraveled material 2
Shaft break 2
Material rupture 2
Source, detachment from 2
Blockage within device or device component 2
Declotting 2
Charred 2
Dislodged 2
Loose or intermittent connection 2
Dissection 2
Flaked 2
Material twisted 2
Device packaging compromised 2
Failure to deliver 2
High Readings 2
Balloon pinhole 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Connection issue 1
Mechanical jam 1
No flow 1
Gas leak 1
Improper device output 1
Inappropriate or unexpected reset 1
Infusion or flow issue 1
Pressure issue 1
Pumping 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
Erratic display 1
Deflation issue 1
Total Device Problems 3134

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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