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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 7
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
EMBA MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Separation Failure 826
Detachment of Device or device Component 459
Detachment Of Device Component 451
Stretched 412
Coil 408
Adverse Event Without Identified Device or Use Problem 388
Physical Resistance / Sticking 171
Entrapment of Device 167
Break 161
Premature Activation 146
Migration or Expulsion of Device 140
Material Protrusion / Extrusion 138
Material Twisted / Bent 134
Migration 130
Unraveled Material 108
Device-Device Incompatibility 84
Positioning Problem 78
Positioning Failure 77
Failure to Advance 76
Difficult to Remove 75
Premature Separation 69
Material Deformation 68
Kinked 59
Unintended Movement 53
Activation, Positioning or Separation Problem 52
Physical Resistance 51
Material Separation 50
Difficult To Position 46
Device Issue 44
Difficult to Advance 38
Difficult or Delayed Positioning 26
Off-Label Use 25
Fracture 24
Deformation Due to Compressive Stress 22
Material Integrity Problem 19
Therapy Delivered to Incorrect Body Area 18
Activation Failure Including Expansion Failures 17
Device Dislodged or Dislocated 15
Difficult to Insert 13
Leak / Splash 13
Malposition of device 13
Separation Problem 12
Material Fragmentation 11
Device Operates Differently Than Expected 9
Unintended Ejection 8
Retraction Problem 8
Shelf Life Exceeded 8
Obstruction of Flow 8
Improper or Incorrect Procedure or Method 8
No Apparent Adverse Event 7
Device Contamination with Chemical or Other Material 7
Mechanical Problem 6
Insufficient Information 6
Inadequacy of Device Shape and/or Size 6
Device Damaged by Another Device 6
Wire 6
Activation Problem 6
Difficult or Delayed Separation 6
Component Missing 6
Delivery System Failure 5
Incomplete or Missing Packaging 5
Flaked 5
Device Markings / Labelling Problem 5
Patient Device Interaction Problem 5
Pusher 5
Tear, Rip or Hole in Device Packaging 5
Component Misassembled 4
Product Quality Problem 4
Use of Device Problem 4
Human-Device Interface Problem 4
Contamination During Use 4
Contamination / decontamination Problem 4
Uncoiled 3
Knotted 3
Failure to Disconnect 3
Device Contaminated during manufacture or shipping 3
Packaging Problem 3
Fitting Problem 3
Microbial Contamination of Device 2
Delivered as Unsterile Product 2
Human Factors Issue 2
Expulsion 2
Compatibility Problem 2
Tip 2
Shunt 2
Biocompatibility 2
Material Frayed 2
Disconnection 2
Patient-Device Incompatibility 2
Other (for use when an appropriate device code cannot be identified) 2
Device Damaged Prior to Use 2
Material Too Soft / Flexible 2
Missing Information 2
Misassembly by Users 1
Difficult to Open or Remove Packaging Material 1
Defective Component 1
Delamination 1
Difficult or Delayed Activation 1
Contamination of Device Ingredient or Reagent 1
Appropriate Term/Code Not Available 1
Total Device Problems 5612

Recalls
Manufacturer Recall Class Date Posted
1 Microvention, Inc. II Feb-13-2020

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