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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 10

Device Problems
Entrapment of device or device component 304
No Known Device Problem 254
Fracture 221
Difficult to remove 169
Unknown (for use when the device problem is not known) 144
Device or device component damaged by another device 115
Wire(s), breakage of 112
Device operates differently than expected 85
Detachment of device component 83
No display or display failure 65
Detachment of device or device component 49
Device, or device fragments remain in patient 45
Balloon rupture 39
Break 39
Kinked 39
Foreign material present in device 39
Device damaged prior to use 34
Use of Device Issue 21
Failure to advance 20
Other (for use when an appropriate device code cannot be identified) 15
Tip breakage 15
Fluid leak 14
No Information 14
Leak 13
Sticking 12
Difficult to insert 12
Physical resistance 12
Device displays error message 12
Aspiration issue 11
Foreign material 11
Stretched 11
Hole in material 10
Material separation 10
Difficult to advance 10
Tears, rips, holes in device, device material 9
Material perforation 9
Device Issue 9
Defective component 8
Unstable 8
Malfunction 8
Torn material 8
Unintended movement 6
Device or device fragments location unknown 6
Device stops intermittently 5
Material fragmentation 5
Air leak 5
Disconnection 4
Device remains activated 4
Difficult to position 4
Split 4
Device, removal of (non-implant) 3
Device Difficult to Setup or Prepare 3
Decrease in pressure 3
Unsealed device packaging 3
Bleed back 3
Blockage within device or device component 2
Bent 2
Burn of device or device component 2
Dislodged 2
Contamination during use 2
Declotting 2
Dissection 2
Flaked 2
Loose or intermittent connection 2
Delivered as unsterile product 2
Source, detachment from 2
Shaft break 2
Unraveled material 2
Tear, rip or hole in device packaging 2
High Readings 2
Material deformation 2
Material twisted 2
No flow 1
Pressure issue 1
Gas leak 1
Improper device output 1
Inappropriate or unexpected reset 1
Balloon pinhole 1
Connection issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Device inoperable 1
Failure to select signal 1
Sterility 1
Peeled 1
Material puncture 1
Failure to power-up 1
Occlusion within device 1
Output energy incorrect 1
Output above specifications 1
Overheating of device or device component 1
Melted 1
Mislabeled 1
Failure, intermittent 1
Material frayed 1
Failure to flush 1
Deflation issue 1
Erratic display 1
Incorrect display 1
Bubble(s) 1
Total Device Problems 2238

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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