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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
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2017
19 22 28 30 2 0 0 0 0 0 0

Device Problems
Material rupture 2563
Balloon rupture 1936
Break 439
Deflation issue 431
Difficult to remove 421
No Known Device Problem 302
Failure to advance 285
Shaft break 253
Balloon burst 223
Inflation issue 205
Detachment of device component 193
Burst 158
Unknown (for use when the device problem is not known) 157
Leak 142
Kinked 140
Entrapment of device or device component 117
Detachment of device or device component 92
Physical resistance 81
Other (for use when an appropriate device code cannot be identified) 75
Foreign material present in device 74
Device damaged prior to use 71
Fracture 70
Improper or incorrect procedure or method 67
Hole in material 64
Balloon leak(s) 60
Use of Device Issue 53
Visibility/palpability 46
Difficult to position 45
Packaging issue 44
Dissection 42
Source, detachment from 40
Balloon pinhole 39
Tears, rips, holes in device, device material 34
Difficult to insert 31
Material perforation 28
Material separation 24
Device, or device fragments remain in patient 23
Sticking 23
Difficult to advance 23
Foreign material 22
Unsealed device packaging 21
Torn material 19
Device markings issue 18
Stretched 15
Material deformation 14
Markings unclear 13
Bent 13
Not Applicable 12
Defective item 12
Device or device fragments location unknown 12
Slippage of device or device component 11
Crack 10
Device remains implanted 10
Device handling issue 9
Device packaging compromised 9
Device or device component damaged by another device 8
Deployment issue 7
Tip breakage 7
Material puncture 7
Device expiration issue 6
Size incorrect for patient 6
Tear, rip or hole in device packaging 6
Malposition of device 6
Folded 5
No Information 5
Unintended movement 5
Component missing 5
Catheter withdrawal interference 5
Sterility 5
Device Difficult to Setup or Prepare 5
Occlusion within device 5
Incorrect measurement 4
Material fragmentation 4
Device, removal of (non-implant) 4
Dislodged or dislocated 4
Traditional use 4
Component or accessory incompatibility 4
No code available 3
Incomplete or missing packaging 3
Blockage within device or device component 3
Contamination during use 3
Delivered as unsterile product 3
Peeled 3
Mislabeled 3
Retraction problem 3
Resistance, inadequate 2
Product quality issue 2
Method, improper/incorrect 2
Loose or intermittent connection 2
Component(s), broken 2
Air leak 2
Failure to flush 2
Implant, removal of 2
Out-of-box failure 2
Unraveled material 2
Positioning Issue 2
Disinfection or Sterilization Issue at User Location 2
Buckled material 1
Device-device incompatibility 1
Difficult to open or remove packaging material 1
Total Device Problems 9502

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 0 0 0 0 0 0 0 0 0
Class II 0 3 1 0 0 1 1 2 0 0 0
Class III 0 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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