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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
18 20 34 22 23 16 12 26 28 26 2

Device Problems
Device operates differently than expected 1720
Failure to deploy 1340
Difficult to remove 1318
Couple, failure to 1164
Unknown (for use when the device problem is not known) 785
Source, detachment from 441
Improper or incorrect procedure or method 437
Detachment of device component 418
Mislocation 321
Use of Device Issue 319
No Known Device Problem 302
Retraction problem 281
Difficult to deploy 279
Break 210
Other (for use when an appropriate device code cannot be identified) 169
Method, improper/incorrect 142
Difficult to insert 118
Resistance, loss of 103
Difficult to position 102
Blockage within device or device component 102
Material rupture 100
Bent 96
Collapse 91
Physical resistance 79
Deployment issue 72
Failure to advance 47
Kinked 42
Loose 42
No Information 37
Failure to separate 30
Leak 30
Therapy delivered to incorrect body area 28
Component missing 27
Premature deployment 26
Migration of device or device component 19
Failure to cut 19
Difficult to advance 18
Device, removal of (non-implant) 17
Device Issue 13
Unintended movement 13
Inaccurate delivery 12
Torn material 11
Mechanical jam 9
Device damaged prior to use 8
Entrapment of device or device component 8
Deflation issue 8
Sticking 8
Stretched 8
Foreign material present in device 7
Dislodged or dislocated 6
Detachment of device or device component 6
Device expiration issue 6
Connection issue 5
Packaging issue 5
Malposition of device 4
Material deformation 4
Misplacement 4
Tears, rips, holes in device, device material 4
Twisting 4
Material separation 4
Occlusion within device 3
Inadequate training 3
Fracture 3
Loose or intermittent connection 3
Expulsion 3
Defective item 3
Malfunction 3
No code available 3
Material twisted 2
Seal, defective 2
Failure to deliver 2
Device or device component damaged by another device 2
Patient-device incompatibility 2
Fluid leak 2
Delivered as unsterile product 2
Misassembled 2
Dislodged 2
Burst 2
Slippage of device or device component 2
Tip breakage 2
Noise 2
Material perforation 2
Unsealed device packaging 2
Rejection 2
Device, or device fragments remain in patient 2
Seal, incorrect 2
Reverse osmosis 1
Shaft, split 1
Shelf life exceeded 1
Failure to select signal 1
Size incorrect for patient 1
Incorrect or inadequate result 1
Device remains implanted 1
Device inoperable 1
Suture line separation 1
Syringe, defective 1
Coiled 1
Component(s), broken 1
Alarm, no lead 1
Failure to Adhere or Bond 1
Total Device Problems 11122

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Feb-15-2017
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Jul-06-2009
3 AccessClosure, Inc., A Cardinal Health Company II Aug-03-2016
4 Cordis Corporation II Jan-25-2013
5 EXP Pharmaceutical Services Corp II Jul-24-2015

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