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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTVENTIVE MEDICAL GROUP, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CELONOVA BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
EMBA MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ENDOSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Separation Failure 649
Detachment Of Device Component 451
Coil 409
Adverse Event Without Identified Device or Use Problem 356
Stretched 323
Detachment of Device or device Component 311
Physical Resistance / Sticking 129
Migration or Expulsion of Device 128
Break 127
Premature Activation 119
Material Protrusion / Extrusion 117
Migration 92
Material Twisted / Bent 88
Unraveled Material 78
Entrapment of Device 77
Positioning Failure 77
Device-Device Incompatibility 75
Failure to Advance 67
Difficult to Remove 66
Kinked 59
Positioning Problem 55
Activation, Positioning or Separation Problem 52
Physical Resistance 51
Material Separation 46
Premature Separation 46
Difficult To Position 46
Material Deformation 45
Device Issue 44
Unintended Movement 43
Difficult to Advance 29
Difficult or Delayed Positioning 21
Therapy Delivered to Incorrect Body Area 18
Off-Label Use 17
Fracture 17
Material Integrity Problem 16
Device Dislodged or Dislocated 14
Activation Failure Including Expansion Failures 13
Malposition of device 12
Material Fragmentation 10
Leak / Splash 9
Deformation Due to Compressive Stress 9
Device Operates Differently Than Expected 9
Shelf Life Exceeded 8
Separation Problem 8
Difficult to Insert 7
Retraction Problem 7
Device Contamination with Chemical or Other Material 7
Insufficient Information 6
Wire 6
Difficult or Delayed Separation 6
No Apparent Adverse Event 6
Flaked 5
Delivery System Failure 5
Activation Problem 5
Component Missing 5
Pusher 5
Tear, Rip or Hole in Device Packaging 5
Device Damaged by Another Device 4
Component Misassembled 4
Patient Device Interaction Problem 4
Use of Device Problem 4
Contamination / decontamination Problem 4
Obstruction of Flow 4
Device Markings / Labelling Problem 3
Improper or Incorrect Procedure or Method 3
Uncoiled 3
Knotted 3
Failure to Disconnect 3
Mechanical Problem 3
Inadequacy of Device Shape and/or Size 3
Fitting Problem 3
Microbial Contamination of Device 2
Packaging Problem 2
Delivered as Unsterile Product 2
Expulsion 2
Unintended Ejection 2
Human Factors Issue 2
Device Contaminated during manufacture or shipping 2
Product Quality Problem 2
Tip 2
Incomplete or Missing Packaging 2
Missing Information 2
Material Too Soft / Flexible 2
Other (for use when an appropriate device code cannot be identified) 2
Device Damaged Prior to Use 2
Contamination During Use 2
Material Frayed 2
Disconnection 2
Defective Component 1
Difficult or Delayed Activation 1
Patient-Device Incompatibility 1
Delamination 1
Human-Device Interface Problem 1
Label 1
Shunt 1
Device Operational Issue 1
Spring loading mechanism problem 1
Aborted Charge 1
Stent 1
Safety Interlock 1
Total Device Problems 4605


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