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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 10
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIOMETRX INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIOSCORE, INC.
  SUBSTANTIALLY EQUIVALENT 5
AVANTEC VASCULAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 3
BIPORE, INC.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 54
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 15
CLEARSTREAM TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 10
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 28
CRYOVASULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 4
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 4
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 7
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 14
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material rupture 765
Balloon rupture 694
Difficult to remove 384
Other (for use when an appropriate device code cannot be identified) 213
Deflation issue 161
Detachment of device component 135
Burst 102
Balloon burst 86
Material separation 82
Detachment of device or device component 73
No Known Device Problem 63
Leak 63
Inflation issue 60
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Break 55
Shaft break 50
Use of Device Issue 48
Entrapment of device or device component 40
Tears, rips, holes in device, device material 28
Physical resistance 28
Device, or device fragments remain in patient 26
Hole in material 26
Retraction problem 25
Failure to advance 22
Dissection 20
Tip breakage 19
Torn material 18
Device damaged prior to use 18
Kinked 17
Sticking 14
Balloon leak(s) 14
Stretched 14
Fracture 14
Balloon pinhole 14
Device or device fragments location unknown 11
Device markings issue 10
Material fragmentation 10
Foreign material 10
No code available 9
Bent 9
Difficult to advance 9
Material perforation 8
Component(s), broken 8
No Information 7
Unraveled material 7
Loose 7
Tear, rip or hole in device packaging 7
Sterility 6
Occlusion within device 6
Packaging issue 6
Failure to fold 5
Unsealed device packaging 5
Difficult to position 5
Dislodged or dislocated 5
Mislabeled 5
Interference 5
Difficult to insert 5
Catheter withdrawal interference 4
Size incorrect for patient 4
Foreign material present in device 4
Contamination during use 4
Material puncture 3
Explanted 3
Split 3
Crack 3
Peeled 3
Material frayed 2
Folded 2
Dislodged 2
Fitting problem 2
Malfunction 2
Improper or incorrect procedure or method 2
Resistance, inadequate 2
Defective component 2
Balloon asymmetrical 2
Out-of-box failure 2
Device operates differently than expected 2
Device or device component damaged by another device 2
Migration of device or device component 2
Pressure, insufficient 1
Buckled material 1
Obstruction within device 1
Device Difficult to Setup or Prepare 1
No display or display failure 1
Fiberoptic break/separation 1
Intraprocedure, fire or flash during 1
Slippage of device or device component 1
Cut in material 1
Protective measure issue 1
Component incompatible 1
Repair 1
Device Issue 1
Unintended movement 1
Shaft, split 1
Burn of device or device component 1
Connection issue 1
Device remains implanted 1
Device, removal of (non-implant) 1
Inadequate training 1
Total Device Problems 3749

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 2 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Sep-25-2012
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Mar-22-2010
3 Boston Scientific Corporation II Mar-25-2010
4 Numed Inc II Dec-15-2009

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