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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, intravascular, cardiovascular
Regulation Description Cardiovascular intravascular filter.
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 13
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 4
CRUX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
VENETEC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Migration of device or device component 347
Difficult to remove 334
Detachment of device or device component 249
No Known Device Problem 248
Malposition of device 238
Extrusion 194
Failure to advance 192
Detachment of device component 179
Material perforation 131
Failure to deploy 116
Deployment issue 115
Difficult to deploy 110
No Information 91
Occlusion within device 85
Failure to expand 83
Fracture 78
Other (for use when an appropriate device code cannot be identified) 64
Premature deployment 47
Material separation 45
Unintended movement 43
Device remains implanted 40
Break 40
Filter 37
Dislodged or dislocated 36
No code available 32
Twisting 31
Misplacement 26
Failure to align 26
Device, or device fragments remain in patient 23
Material puncture 21
Bent 19
Device operates differently than expected 19
Material deformation 17
Inaccurate delivery 17
Implant, removal of 15
Strut fracture 15
Unknown (for use when the device problem is not known) 13
Positioning Issue 13
Entrapment of device or device component 12
Difficult to insert 11
Kinked 11
Device or device fragments location unknown 9
Device Issue 8
Packaging issue 8
Material fragmentation 8
Material frayed 7
Difficult to advance 7
Difficult to open or close 7
Improper or incorrect procedure or method 7
Physical resistance 6
Filter break(s) 6
Delivered as unsterile product 6
Sticking 6
Therapy delivered to incorrect body area 6
Retraction problem 6
Tears, rips, holes in device, device material 5
Malfunction 5
Device, removal of (non-implant) 5
Use of Device Issue 5
Torn material 5
Foreign material present in device 4
Expulsion 4
Tear, rip or hole in device packaging 4
Failure to unfold or unwrap 4
Leak 4
Material erosion 4
Dislodged 4
Failure to Adhere or Bond 4
Component(s), broken 4
Displacement 3
Explanted 3
Filter, inadequate 3
Difficult to position 3
Unsealed device packaging 3
Peeled 3
Defective item 3
Buckled material 3
Failure to deliver 3
Impedance issue 3
Inadequate user interface 3
Device or device component damaged by another device 2
Device markings issue 2
Material Distortion 2
Material integrity issue 2
Material Protrusion 2
Component missing 2
Fitting problem 2
Connection issue 2
Patient-device incompatibility 2
Mechanical issue 2
Material rupture 2
Difficult to fold or unfold 2
Disconnection 2
Material disintegration 1
Material discolored 1
Component incompatible 1
Continuous mode failure 1
Deflation issue 1
Degraded 1
Blockage within device or device component 1
Total Device Problems 3687

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

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Interventional Systems II Nov-24-2007
2 Bard Peripheral Vascular Inc II Mar-08-2016
3 Bard Peripheral Vascular Inc II Feb-01-2016
4 Bard Peripheral Vascular Inc II Feb-01-2007
5 Boston Scientific III May-10-2007
6 Cordis Corporation II Oct-25-2013
7 Cordis Corporation I Aug-07-2013

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