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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheters, transluminal coronary angioplasty, percutaneous
Regulation Description Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Product CodeLOX
Regulation Number 870.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
19 22 28 30 2 0 0 0 0 0

Device Problems
Material rupture 2001
Balloon rupture 1936
Deflation issue 396
Difficult to remove 389
Break 301
No Known Device Problem 260
Shaft break 253
Balloon burst 223
Failure to advance 210
Inflation issue 182
Detachment of device component 178
Unknown (for use when the device problem is not known) 157
Burst 128
Kinked 119
Leak 115
Entrapment of device or device component 97
Physical resistance 81
Detachment of device or device component 76
Other (for use when an appropriate device code cannot be identified) 75
Foreign material present in device 71
Fracture 66
Improper or incorrect procedure or method 64
Balloon leak(s) 60
Use of Device Issue 53
Device damaged prior to use 53
Hole in material 48
Visibility/palpability 46
Packaging issue 44
Difficult to position 43
Dissection 42
Source, detachment from 40
Balloon pinhole 39
Tears, rips, holes in device, device material 34
Difficult to insert 31
Material separation 24
Material perforation 24
Sticking 23
Device, or device fragments remain in patient 23
Foreign material 22
Unsealed device packaging 21
Difficult to advance 21
Device markings issue 17
Torn material 16
Stretched 15
Markings unclear 13
Device or device fragments location unknown 12
Not Applicable 12
Bent 11
Crack 10
Device remains implanted 10
Slippage of device or device component 10
Device packaging compromised 9
Device handling issue 8
Material deformation 7
Defective item 7
Tip breakage 7
Material puncture 7
Size incorrect for patient 6
Malposition of device 6
Tear, rip or hole in device packaging 6
Deployment issue 6
Catheter withdrawal interference 5
Device or device component damaged by another device 5
No Information 5
Unintended movement 5
Folded 5
Component missing 5
Sterility 5
Device expiration issue 5
Material fragmentation 4
Occlusion within device 4
Incorrect measurement 4
Device Difficult to Setup or Prepare 4
Traditional use 4
Component or accessory incompatibility 4
Device, removal of (non-implant) 4
Incomplete or missing packaging 3
No code available 3
Dislodged or dislocated 3
Delivered as unsterile product 3
Mislabeled 3
Peeled 3
Blockage within device or device component 3
Contamination during use 3
Component(s), broken 2
Air leak 2
Failure to flush 2
Product quality issue 2
Resistance, inadequate 2
Method, improper/incorrect 2
Loose or intermittent connection 2
Positioning Issue 2
Implant, removal of 2
Unraveled material 2
Out-of-box failure 2
Tracking 1
Twisting 1
Source, leak(s) from 1
Failure to deliver 1
Wire(s), breakage of 1
Total Device Problems 8383

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 0 0 0 0 0 0 0 0
Class II 0 3 1 0 0 1 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Feb-03-2009
2 Boston Scientific Corporation II Dec-24-2008
3 Boston Scientific Corporation II Aug-26-2008
4 Boston Scientific Corporation II Aug-26-2008
5 Cordis Corporation II Aug-28-2014
6 Cordis Corporation II Jun-11-2014
7 Cordis Corporation II Sep-21-2012
8 Cordis Corporation I Feb-06-2008
9 Medtronic Vascular, Inc. II Sep-30-2013

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