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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 6
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
Balloon rupture 1936
Material rupture 1913
Deflation issue 390
Difficult to remove 388
Break 286
No Known Device Problem 255
Shaft break 253
Balloon burst 223
Failure to advance 201
Inflation issue 182
Detachment of device component 173
Unknown (for use when the device problem is not known) 157
Burst 122
Kinked 119
Leak 115
Entrapment of device or device component 95
Physical resistance 81
Other (for use when an appropriate device code cannot be identified) 75
Detachment of device or device component 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 51
Hole in material 46
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 perforation 24
Material separation 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
Not Applicable 12
Device or device fragments location unknown 12
Bent 11
Slippage of device or device component 10
Crack 10
Device remains implanted 10
Device packaging compromised 9
Device handling issue 8
Defective item 7
Tip breakage 7
Material puncture 7
Deployment issue 6
Tear, rip or hole in device packaging 6
Malposition of device 6
Size incorrect for patient 6
Material deformation 6
Unintended movement 5
Catheter withdrawal interference 5
Folded 5
Device expiration issue 5
No Information 5
Sterility 5
Component missing 5
Incorrect measurement 4
Device Difficult to Setup or Prepare 4
Occlusion within device 4
Traditional use 4
Component or accessory incompatibility 4
Device or device component damaged by another device 4
Material fragmentation 4
Device, removal of (non-implant) 4
Peeled 3
Blockage within device or device component 3
Incomplete or missing packaging 3
Delivered as unsterile product 3
Mislabeled 3
Dislodged or dislocated 3
No code available 3
Contamination during use 3
Product quality issue 2
Unraveled material 2
Method, improper/incorrect 2
Air leak 2
Out-of-box failure 2
Resistance, inadequate 2
Positioning Issue 2
Failure to flush 2
Component(s), broken 2
Implant, removal of 2
Channeling 1
Collapse 1
Mislocation 1
Nonstandard device or device component 1
Fluid leak 1
Device disinfection or sterilization issue 1
Total Device Problems 8238

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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