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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter for crossing total occlusions
Regulation Description Percutaneous catheter.
Definition To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Product CodePDU
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 4
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
RA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVASCULAR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Material separation 98
Detachment of device or device component 37
Fracture 34
Retraction problem 28
Device-device incompatibility 28
Device inoperable 19
Torn material 17
Material twisted 14
Break 9
Kinked 8
Difficult to remove 8
Failure to advance 6
Material deformation 5
Overheating of device or device component 5
Noise, Audible 5
Bent 4
Difficult to deploy 4
Difficult or delayed activation 4
Detachment of device component 3
Material puncture 3
No Known Device Problem 3
Unraveled material 2
Use of Device Issue 2
Structural problem 2
Entrapment of device or device component 2
Leak 2
Material frayed 2
Hole in material 2
Connection issue 2
Difficult to advance 2
Dislodged or dislocated 2
Extrusion 2
Foreign material present in device 2
Material integrity issue 1
Mechanical jam 1
Deployment issue 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Crack 1
Peeled 1
Difficult to position 1
Positioning Issue 1
Total Device Problems 375

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Volcano Corporation II Sep-02-2015

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