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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 2
BACCHUS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 15
DOW
  SUBSTANTIALLY EQUIVALENT 2
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FOXHOLLOW TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
IDEV TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENA
  SUBSTANTIALLY EQUIVALENT 3
PATHWAY MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 16
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 415
Entrapment of device or device component 144
Aspiration issue 77
Material separation 67
Detachment of device or device component 50
Break 45
Material deformation 41
Device operates differently than expected 35
Difficult to remove 35
Detachment of device component 23
Material fragmentation 23
Fracture 17
Device or device component damaged by another device 16
Device-device incompatibility 9
Torn material 8
Failure to advance 7
Foreign material present in device 6
Improper or incorrect procedure or method 6
Use of Device Issue 5
Retraction problem 5
Material rupture 5
Material puncture 5
Hole in material 5
Device stops intermittently 4
No Information 4
Mechanical jam 4
Defective item 3
Incompatibility problem 3
Tear, rip or hole in device packaging 3
Difficult to advance 3
Physical resistance 3
Shipping damage or problem 3
Leak 3
Device clogged 3
Contamination during use 2
Decoupling 2
Kinked 2
Blockage within device or device component 2
Poor quality image 2
Stretched 2
Difficult to open or close 2
Obstruction within device 2
Cut in material 2
Split 2
Material perforation 2
Incorrect device or component shipped 2
Device misassembled during manufacturing or shipping 2
Material twisted 2
Unintended movement 2
Noise, Audible 1
Packaging issue 1
Material Distortion 1
Material integrity issue 1
Material torqued 1
Device damaged prior to use 1
Wire(s), breakage of 1
Device Issue 1
Escape 1
Failure to shut off 1
Failure to cut 1
Buckled material 1
Component or accessory incompatibility 1
Device inoperable 1
Sticking 1
Metal shedding debris 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Difficult to position 1
Failure to prime 1
Melted 1
Device remains implanted 1
Fluid leak 1
Failure to fold 1
Knotted 1
Material disintegration 1
Electrical issue 1
Crack 1
Component(s), broken 1
Burn of device or device component 1
Total Device Problems 1145

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 2 1 3 1 0 1 1 0 0 3 4
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-24-2009
2 Boston Scientific Corporation II Apr-10-2017
3 Cardiovascular Systems Inc II Apr-10-2017
4 Cardiovascular Systems Inc II Apr-10-2017
5 Cardiovascular Systems Inc II Feb-22-2017
6 Cardiovascular Systems Inc II Jun-27-2016
7 Cardiovascular Systems, Inc. I Aug-14-2014
8 Cardiovascular Systems, Inc. II Jul-09-2012
9 Cardiovascular Systems, Inc. II Sep-10-2009
10 Cardiovascular Systems, Inc. II Apr-17-2009
11 Cordis Corporation II Oct-31-2008
12 Elana, Inc. II Apr-18-2013
13 Ev3, Inc. II Mar-18-2010
14 Kensey Nash Corp II Jul-23-2007
15 Kensey Nash Corp II Mar-08-2007
16 Spectranetics Corp. II Feb-05-2016
17 Spectranetics Corporation II Nov-28-2016

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