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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 6856
Difficult to Remove 4620
Appropriate Term/Code Not Available 3895
Filter 2302
Malposition of device 2081
Unintended Movement 1863
Adverse Event Without Identified Device or Use Problem 1640
Migration or Expulsion of Device 1622
Fracture 1289
Failure to Align 1278
Patient Device Interaction Problem 1116
Detachment of Device or device Component 1059
Extrusion 584
Failure to Advance 274
Migration 270
Entrapment of Device 203
Activation Failure Including Expansion Failures 200
Activation, Positioning or Separation Problem 177
Occlusion Within Device 164
Obstruction of Flow 133
Material Deformation 106
Difficult or Delayed Positioning 97
Material Separation 91
Positioning Failure 80
Kinked 75
Positioning Problem 71
Detachment Of Device Component 63
Premature Activation 56
Material Puncture / Hole 54
Difficult to Advance 53
Break 49
Material Perforation 45
Bent 44
Material Twisted / Bent 40
Complete Blockage 34
Device Dislodged or Dislocated 33
Catheter 25
Device Handling Problem 23
Difficult to Insert 23
Retraction Problem 20
Difficult or Delayed Activation 19
Material Frayed 18
Device Operates Differently Than Expected 17
Material Fragmentation 15
Material Erosion 12
Tip 12
Failure to Unfold or Unwrap 11
Therapy Delivered to Incorrect Body Area 11
Device Or Device Fragments Location Unknown 10
Torn Material 9
Other (for use when an appropriate device code cannot be identified) 9
Device Difficult to Setup or Prepare 9
Filtration Problem 9
Device Issue 8
Leak / Splash 7
Stent 7
Material Split, Cut or Torn 7
Improper or Incorrect Procedure or Method 7
Activation Problem 6
Difficult to Open or Close 6
Difficult To Position 6
Material Protrusion / Extrusion 6
Collapse 6
Split 6
Use of Device Problem 6
Deformation Due to Compressive Stress 6
Crack 6
Sticking 5
Physical Resistance 5
Cannula Guide 5
Defective Component 5
No Apparent Adverse Event 5
Inadequate User Interface 4
Failure to Capture 4
Expulsion 4
Device Contamination with Chemical or Other Material 4
Partial Blockage 4
Packaging Problem 4
Component or Accessory Incompatibility 4
Strut fracture 3
Shaft 3
Device Damaged by Another Device 3
Material Rupture 3
Difficult to Flush 3
Failure To Adhere Or Bond 3
Delivered as Unsterile Product 3
Mechanical Problem 3
Unsealed Device Packaging 3
Material Distortion 3
Device Operational Issue 3
Device Markings / Labelling Problem 3
Patient-Device Incompatibility 3
Burst Container or Vessel 2
Device Slipped 2
Device Subassembly 2
Hole In Material 2
Component Missing 2
Separation Failure 2
Failure to Disconnect 2
Film 2
Total Device Problems 33067

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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