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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 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS, A JOHNSON & JOHNSON CO.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Insufficient Information 5558
Difficult to Remove 4151
Appropriate Term/Code Not Available 2706
Filter 1920
Unintended Movement 1813
Malposition of device 1748
Adverse Event Without Identified Device or Use Problem 1491
Migration or Expulsion of Device 1439
Fracture 1056
Failure to Align 982
Detachment of Device or device Component 893
Patient Device Interaction Problem 752
Extrusion 583
Failure to Advance 272
Activation Failure Including Expansion Failures 192
Activation, Positioning or Separation Problem 166
Occlusion Within Device 164
Migration 161
Entrapment of Device 103
Difficult or Delayed Positioning 95
Material Separation 89
Material Deformation 87
Positioning Failure 79
Obstruction of Flow 76
Kinked 75
Detachment Of Device Component 62
Premature Activation 56
Difficult to Advance 49
Material Puncture / Hole 49
Positioning Problem 48
Break 46
Bent 44
Material Perforation 43
Complete Blockage 34
Device Dislodged or Dislocated 33
Material Twisted / Bent 30
Catheter 24
Device Handling Problem 23
Difficult to Insert 23
Retraction Problem 20
Material Frayed 18
Device Operates Differently Than Expected 17
Material Fragmentation 15
Difficult or Delayed Activation 14
Tip 12
Material Erosion 11
Failure to Unfold or Unwrap 11
Therapy Delivered to Incorrect Body Area 11
Device Or Device Fragments Location Unknown 10
Torn Material 9
Filtration Problem 9
Other (for use when an appropriate device code cannot be identified) 9
Device Difficult to Setup or Prepare 9
Device Issue 8
Leak / Splash 7
Stent 7
Material Split, Cut or Torn 7
Improper or Incorrect Procedure or Method 7
Deformation Due to Compressive Stress 6
Difficult to Open or Close 6
Use of Device Problem 6
Difficult To Position 6
Crack 6
Split 6
Collapse 5
Sticking 5
Material Protrusion / Extrusion 5
Activation Problem 5
No Apparent Adverse Event 5
Defective Component 5
Physical Resistance 5
Failure to Capture 4
Component or Accessory Incompatibility 4
Expulsion 4
Partial Blockage 4
Device Contamination with Chemical or Other Material 4
Cannula Guide 4
Inadequate User Interface 4
Packaging Problem 4
Mechanical Problem 3
Material Rupture 3
Material Distortion 3
Device Markings / Labelling Problem 3
Unsealed Device Packaging 3
Failure To Adhere Or Bond 3
Patient-Device Incompatibility 3
Device Operational Issue 3
Difficult to Flush 3
Strut fracture 3
Delivered as Unsterile Product 3
Shaft 3
Balloon 2
Unknown (for use when the device problem is not known) 2
Component Missing 2
Burst Container or Vessel 2
Tear, Rip or Hole in Device Packaging 2
Device Damaged by Another Device 2
Separation Failure 2
Hole In Material 2
Device Subassembly 2
Total Device Problems 27583

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Mar-08-2016
2 Bard Peripheral Vascular Inc II Feb-01-2016
3 Cook Medical Incorporated III Mar-19-2019

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