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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 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Insufficient Information 7040
Difficult to Remove 4654
Appropriate Term/Code Not Available 4028
Filter 2369
Malposition of device 2087
Unintended Movement 1866
Adverse Event Without Identified Device or Use Problem 1664
Migration or Expulsion of Device 1628
Failure to Align 1333
Fracture 1324
Patient Device Interaction Problem 1172
Detachment of Device or device Component 1023
Extrusion 566
Migration 283
Failure to Advance 270
Entrapment of Device 207
Activation Failure Including Expansion Failures 167
Occlusion Within Device 163
Activation, Positioning or Separation Problem 151
Obstruction of Flow 139
Material Deformation 105
Difficult or Delayed Positioning 96
Material Separation 87
Positioning Failure 79
Kinked 75
Positioning Problem 73
Detachment Of Device Component 59
Premature Activation 57
Difficult to Advance 53
Material Puncture / Hole 53
Break 46
Material Perforation 45
Material Twisted / Bent 44
Bent 43
Complete Blockage 34
Device Dislodged or Dislocated 34
Catheter 25
Difficult to Insert 24
Device Handling Problem 23
Difficult or Delayed Activation 19
Material Frayed 18
Retraction Problem 18
Device Operates Differently Than Expected 16
Material Fragmentation 13
Material Erosion 11
Tip 11
Failure to Unfold or Unwrap 10
Device Or Device Fragments Location Unknown 10
Therapy Delivered to Incorrect Body Area 10
Device Difficult to Setup or Prepare 9
Activation Problem 9
Filtration Problem 9
Torn Material 9
Device Issue 8
Leak / Splash 7
Stent 7
Material Split, Cut or Torn 7
Improper or Incorrect Procedure or Method 6
Difficult to Open or Close 6
Difficult To Position 6
Material Protrusion / Extrusion 6
Collapse 6
Split 6
Deformation Due to Compressive Stress 6
Crack 6
Sticking 5
Physical Resistance 5
Cannula Guide 5
Use of Device Problem 5
Defective Component 5
No Apparent Adverse Event 5
Failure to Capture 4
Component or Accessory Incompatibility 4
Expulsion 4
Device Contamination with Chemical or Other Material 4
Packaging Problem 4
Device Damaged by Another Device 3
Material Rupture 3
Difficult to Flush 3
Tear, Rip or Hole in Device Packaging 3
Delivered as Unsterile Product 3
Partial Blockage 3
Failure To Adhere Or Bond 3
Mechanical Problem 3
Shaft 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
Hole In Material 2
Component Missing 2
Cut In Material 2
Unknown (for use when the device problem is not known) 2
Failure to Disconnect 2
Film 2
Defective Device 2
Dent in Material 2
Total Device Problems 33550

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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