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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 1
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 2329
Balloon rupture 1936
Deflation issue 415
Difficult to remove 404
Break 379
No Known Device Problem 273
Failure to advance 258
Shaft break 253
Balloon burst 223
Inflation issue 201
Detachment of device component 186
Unknown (for use when the device problem is not known) 157
Burst 150
Kinked 132
Leak 132
Entrapment of device or device component 109
Detachment of device or device component 88
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 66
Device damaged prior to use 63
Balloon leak(s) 60
Hole in material 55
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 27
Material separation 24
Device, or device fragments remain in patient 23
Sticking 23
Difficult to advance 22
Foreign material 22
Unsealed device packaging 21
Device markings issue 17
Torn material 16
Stretched 15
Markings unclear 13
Bent 13
Defective item 12
Device or device fragments location unknown 12
Not Applicable 12
Material deformation 11
Slippage of device or device component 11
Device remains implanted 10
Crack 10
Device packaging compromised 9
Device handling issue 8
Tip breakage 7
Material puncture 7
Size incorrect for patient 6
Malposition of device 6
Tear, rip or hole in device packaging 6
Device or device component damaged by another device 6
Deployment issue 6
Catheter withdrawal interference 5
No Information 5
Unintended movement 5
Folded 5
Component missing 5
Sterility 5
Device Difficult to Setup or Prepare 5
Device expiration issue 5
Material fragmentation 4
Incorrect measurement 4
Occlusion within device 4
Traditional use 4
Device, removal of (non-implant) 4
Component or accessory incompatibility 4
Dislodged or dislocated 4
No code available 3
Incomplete or missing packaging 3
Peeled 3
Delivered as unsterile product 3
Mislabeled 3
Blockage within device or device component 3
Contamination during use 3
Component(s), broken 2
Air leak 2
Failure to flush 2
Method, improper/incorrect 2
Loose or intermittent connection 2
Product quality issue 2
Resistance, inadequate 2
Retraction problem 2
Implant, removal of 2
Unraveled material 2
Out-of-box failure 2
Positioning Issue 2
Disinfection or Sterilization Issue at User Location 2
Device disinfection or sterilization issue 1
Difficult to open or remove packaging material 1
Device-device incompatibility 1
Total Device Problems 9031

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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