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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 5
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 284
Difficult to remove 280
Detachment of device or device component 228
Failure to advance 192
Detachment of device component 179
Malposition of device 173
No Known Device Problem 140
Extrusion 131
Material perforation 122
Failure to deploy 115
Deployment issue 114
Difficult to deploy 109
Failure to expand 81
Occlusion within device 77
Other (for use when an appropriate device code cannot be identified) 64
Fracture 63
Premature deployment 47
No Information 42
Device remains implanted 40
Material separation 40
Break 38
Filter 37
Dislodged or dislocated 36
Unintended movement 32
Twisting 31
Misplacement 26
Device, or device fragments remain in patient 23
Material puncture 21
Bent 19
Device operates differently than expected 18
Inaccurate delivery 17
Implant, removal of 15
Failure to align 15
Material deformation 15
No code available 15
Strut fracture 15
Positioning Issue 13
Unknown (for use when the device problem is not known) 13
Entrapment of device or device component 12
Difficult to insert 11
Kinked 11
Device or device fragments location unknown 9
Packaging issue 8
Difficult to advance 7
Difficult to open or close 7
Improper or incorrect procedure or method 7
Device Issue 7
Material fragmentation 7
Material frayed 6
Filter break(s) 6
Delivered as unsterile product 6
Sticking 6
Retraction problem 6
Physical resistance 6
Device, removal of (non-implant) 5
Malfunction 5
Use of Device Issue 5
Torn material 5
Therapy delivered to incorrect body area 5
Tears, rips, holes in device, device material 5
Failure to unfold or unwrap 4
Material erosion 4
Dislodged 4
Component(s), broken 4
Foreign material present in device 4
Tear, rip or hole in device packaging 4
Failure to deliver 3
Defective item 3
Buckled material 3
Impedance issue 3
Inadequate user interface 3
Failure to Adhere or Bond 3
Displacement 3
Explanted 3
Filter, inadequate 3
Difficult to position 3
Unsealed device packaging 3
Peeled 3
Leak 3
Mechanical issue 2
Material rupture 2
Difficult to fold or unfold 2
Disconnection 2
Device or device component damaged by another device 2
Device markings issue 2
Material integrity issue 2
Material Protrusion 2
Connection issue 2
Patient-device incompatibility 2
Component missing 2
Out-of-box failure 1
Underdelivery 1
Wire(s), breakage of 1
Metal shedding debris 1
Fitting problem 1
Device damaged prior to use 1
Defective component 1
Unfold, difficult to 1
Delivery System Issue, No Description 1
Device disinfection or sterilization issue 1
Total Device Problems 3167

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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