• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 9
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 2456
Balloon rupture 1936
Deflation issue 422
Difficult to remove 417
Break 415
No Known Device Problem 291
Failure to advance 267
Shaft break 253
Balloon burst 223
Inflation issue 202
Detachment of device component 190
Unknown (for use when the device problem is not known) 157
Burst 154
Leak 139
Kinked 137
Entrapment of device or device component 111
Detachment of device or device component 90
Physical resistance 81
Other (for use when an appropriate device code cannot be identified) 75
Foreign material present in device 72
Fracture 70
Device damaged prior to use 66
Improper or incorrect procedure or method 66
Balloon leak(s) 60
Hole in material 56
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 22
Foreign material 22
Unsealed device packaging 21
Device markings issue 18
Torn material 17
Stretched 15
Markings unclear 13
Bent 13
Defective item 12
Device or device fragments location unknown 12
Material deformation 12
Not Applicable 12
Slippage of device or device component 11
Crack 10
Device remains implanted 10
Device packaging compromised 9
Device handling issue 8
Tip breakage 7
Material puncture 7
Device expiration issue 6
Size incorrect for patient 6
Tear, rip or hole in device packaging 6
Device or device component damaged by another device 6
Malposition of device 6
Deployment issue 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
Incorrect measurement 4
Occlusion within device 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 9279

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

-
-