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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
No Information 538
No Known Device Problem 496
Difficult to remove 466
Migration of device or device component 433
Malposition of device 374
Detachment of device or device component 331
Extrusion 251
No code available 231
Failure to advance 194
Detachment of device component 180
Fracture 160
Material perforation 136
Deployment issue 135
Difficult to deploy 129
Failure to deploy 125
Occlusion within device 102
Failure to expand 97
Other (for use when an appropriate device code cannot be identified) 64
Unintended movement 58
Premature deployment 52
Material separation 51
Break 45
Device remains implanted 40
Dislodged or dislocated 37
Filter 37
Failure to align 36
Material puncture 34
Twisting 31
Difficult to advance 28
Misplacement 26
Material deformation 26
Bent 26
Entrapment of device or device component 24
Device, or device fragments remain in patient 23
Device operates differently than expected 19
Positioning Issue 18
Inaccurate delivery 17
Device handling issue 17
Implant, removal of 15
Strut fracture 15
Unknown (for use when the device problem is not known) 13
Kinked 12
Difficult to insert 11
Packaging issue 9
Device or device fragments location unknown 9
Material fragmentation 9
Material frayed 9
Device Difficult to Setup or Prepare 8
Retraction problem 8
Filter break(s) 8
Device Issue 8
Torn material 7
Improper or incorrect procedure or method 7
Difficult to open or close 7
Delivered as unsterile product 6
Physical resistance 6
Failure to unfold or unwrap 6
Sticking 6
Therapy delivered to incorrect body area 6
Dislodged 5
Device, removal of (non-implant) 5
Leak 5
Malfunction 5
Tears, rips, holes in device, device material 5
Failure to capture 5
Use of Device Issue 5
Tear, rip or hole in device packaging 4
Failure to Adhere or Bond 4
Material erosion 4
Component(s), broken 4
Foreign material present in device 4
Component or accessory incompatibility 4
Expulsion 4
Unsealed device packaging 3
Filter, inadequate 3
Peeled 3
Difficult to position 3
Defective item 3
Inadequate user interface 3
Material rupture 3
Impedance issue 3
Displacement 3
Patient-device incompatibility 3
Buckled material 3
Difficult to flush 3
Explanted 3
Failure to deliver 3
Component missing 2
Connection issue 2
Material twisted 2
Material integrity issue 2
Device markings issue 2
Disconnection 2
Device damaged prior to use 2
Material Distortion 2
Mechanical issue 2
Collapse 2
Instruction for use issue 2
Difficult to fold or unfold 2
Fitting problem 2
Total Device Problems 5403

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