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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 2202
Balloon rupture 1936
Deflation issue 408
Difficult to remove 393
Break 355
No Known Device Problem 268
Shaft break 253
Failure to advance 239
Balloon burst 223
Inflation issue 195
Detachment of device component 182
Unknown (for use when the device problem is not known) 157
Burst 144
Leak 129
Kinked 125
Entrapment of device or device component 103
Detachment of device or device component 83
Physical resistance 81
Other (for use when an appropriate device code cannot be identified) 75
Foreign material present in device 72
Fracture 67
Improper or incorrect procedure or method 65
Device damaged prior to use 60
Balloon leak(s) 60
Use of Device Issue 53
Hole in material 52
Visibility/palpability 46
Packaging issue 44
Difficult to position 44
Dissection 42
Source, detachment from 40
Balloon pinhole 39
Tears, rips, holes in device, device material 34
Difficult to insert 31
Material perforation 27
Material separation 24
Device, or device fragments remain in patient 23
Sticking 23
Foreign material 22
Unsealed device packaging 21
Difficult to advance 21
Device markings issue 17
Torn material 16
Stretched 15
Markings unclear 13
Bent 13
Device or device fragments location unknown 12
Not Applicable 12
Slippage of device or device component 11
Crack 10
Device remains implanted 10
Defective item 9
Device packaging compromised 9
Device handling issue 8
Material deformation 8
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
Device or device component damaged by another device 6
Catheter withdrawal interference 5
Unintended movement 5
No Information 5
Folded 5
Sterility 5
Component missing 5
Device expiration issue 5
Material fragmentation 4
Incorrect measurement 4
Device Difficult to Setup or Prepare 4
Occlusion within device 4
Traditional use 4
Device, removal of (non-implant) 4
Component or accessory incompatibility 4
Dislodged or dislocated 3
No code available 3
Incomplete or missing packaging 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
Implant, removal of 2
Out-of-box failure 2
Unraveled material 2
Positioning Issue 2
Disinfection or Sterilization Issue at User Location 2
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Device disinfection or sterilization issue 1
Incorrect device or component shipped 1
Total Device Problems 8783

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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