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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, neurovascular embolization
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
KANEKA MEDICAL AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2494 2494
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 552 552

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 3246 3246
Physical Resistance/Sticking 2316 2316
Premature Separation 1319 1319
Physical Resistance 1078 1078
Separation Failure 691 691
Material Deformation 644 644
Adverse Event Without Identified Device or Use Problem 617 617
Detachment Of Device Component 583 583
Mechanical Problem 483 483
Break 478 478
Detachment of Device or Device Component 453 453
Stretched 366 366
Difficult or Delayed Separation 294 294
Kinked 267 267
Device Handling Problem 211 211
Device Operates Differently Than Expected 208 208
Device Damaged Prior to Use 202 202
Fracture 198 198
Mechanical Jam 191 191
Failure to Fold 183 183
Premature Activation 178 178
Migration 160 160
Difficult to Advance 158 158
Positioning Failure 132 132
Unraveled Material 121 121
Migration or Expulsion of Device 119 119
Difficult to Remove 111 111
Difficult or Delayed Activation 110 110
Bent 97 97
Retraction Problem 94 94
Material Twisted/Bent 93 93
Out-Of-Box Failure 90 90
Device-Device Incompatibility 78 78
Difficult To Position 54 54
Material Protrusion/Extrusion 47 47
Difficult or Delayed Positioning 45 45
Inadequacy of Device Shape and/or Size 44 44
Appropriate Term/Code Not Available 43 43
Device Dislodged or Dislocated 35 35
Deformation Due to Compressive Stress 31 31
Unintended Movement 31 31
Material Separation 31 31
Positioning Problem 29 29
Expulsion 29 29
Device Fell 25 25
Entrapment of Device 25 25
Activation, Positioning or Separation Problem 23 23
Separation Problem 22 22
Material Too Rigid or Stiff 22 22
Defective Device 21 21
Insufficient Information 20 20
Device Markings/Labelling Problem 16 16
Malposition of Device 16 16
Fluid/Blood Leak 15 15
No Apparent Adverse Event 13 13
Patient-Device Incompatibility 11 11
Component Missing 11 11
Material Frayed 9 9
Material Integrity Problem 9 9
Activation Failure 8 8
Difficult to Insert 7 7
Device Difficult to Setup or Prepare 7 7
Collapse 6 6
Component Misassembled 5 5
Inadequate User Interface 5 5
Device Damaged by Another Device 4 4
Difficult to Open or Remove Packaging Material 4 4
Material Split, Cut or Torn 4 4
Noise, Audible 4 4
Activation Problem 4 4
Knotted 4 4
Device Slipped 4 4
Defective Component 4 4
Tear, Rip or Hole in Device Packaging 3 3
Folded 3 3
Sticking 3 3
Leak/Splash 3 3
Unsealed Device Packaging 3 3
Contamination 3 3
Unintended Ejection 3 3
Contamination /Decontamination Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Physical Property Issue 3 3
Chemical Problem 2 2
Electrical Overstress 2 2
Device Operational Issue 2 2
Crack 2 2
Accessory Incompatible 2 2
Misconnection 2 2
Looping 2 2
Material Fragmentation 2 2
Use of Device Problem 2 2
Off-Label Use 2 2
Peeled/Delaminated 2 2
Split 2 2
High Sensing Threshold 1 1
Wrinkled 1 1
Dull, Blunt 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6888 6888
No Clinical Signs, Symptoms or Conditions 3286 3286
No Patient Involvement 377 377
No Known Impact Or Consequence To Patient 297 297
Headache 125 125
Aneurysm 100 100
Thrombus 78 78
Neurological Deficit/Dysfunction 61 61
Rupture 48 48
Thrombosis 47 47
Ischemia 40 40
Death 40 40
Stroke/CVA 38 38
Hemorrhage, Subarachnoid 37 37
Visual Disturbances 37 37
Weakness 37 37
Device Embedded In Tissue or Plaque 32 32
Hemorrhage/Bleeding 30 30
Infarction, Cerebral 28 28
Hemorrhage, Cerebral 26 26
Insufficient Information 26 26
Thrombosis/Thrombus 25 25
Reaction 25 25
Ischemia Stroke 24 24
Foreign Body In Patient 24 24
Intracranial Hemorrhage 23 23
Thromboembolism 20 20
Ruptured Aneurysm 19 19
Vasoconstriction 18 18
No Code Available 16 16
Transient Ischemic Attack 15 15
Patient Problem/Medical Problem 14 14
Occlusion 13 13
Unspecified Infection 13 13
No Information 12 12
Perforation of Vessels 12 12
Vomiting 12 12
Injury 11 11
Hydrocephalus 11 11
Nausea 11 11
Paresis 11 11
Perforation 11 11
Fever 11 11
Inflammation 10 10
Hematoma 10 10
Pain 8 8
Vitreous Floaters 8 8
Embolism 8 8
Dizziness 8 8
Dysphasia 7 7
Visual Impairment 7 7
Embolism/Embolus 7 7
Embolus 7 7
Foreign Body Reaction 6 6
Extravasation 6 6
High Blood Pressure/ Hypertension 6 6
Muscle Weakness 6 6
Convulsion/Seizure 6 6
Lethargy 6 6
Blood Loss 5 5
Obstruction/Occlusion 5 5
Neck Pain 5 5
Cognitive Changes 5 5
Abscess 5 5
Abdominal Pain 4 4
Cardiac Arrest 4 4
Liver Damage/Dysfunction 4 4
Neuropathy 4 4
Numbness 4 4
Stenosis 4 4
Vascular System (Circulation), Impaired 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Therapeutic Response, Decreased 3 3
Necrosis 3 3
Hemoptysis 3 3
Fatigue 3 3
Edema 3 3
Pulmonary Emphysema 2 2
Chest Pain 2 2
Diarrhea 2 2
Bacterial Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Brain Injury 2 2
Loss of Vision 2 2
Coma 2 2
Discomfort 2 2
Toxicity 2 2
Swelling/ Edema 2 2
Cerebral Edema 2 2
Gastrointestinal Hemorrhage 2 2
Unspecified Nervous System Problem 2 2
Ascites 2 2
Vaso-Vagal Response 1 1
Decreased Sensitivity 1 1
Multiple Organ Failure 1 1
Nervous System Injury 1 1
Vascular Dissection 1 1
Foreign Body Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Oct-20-2022
2 BALT USA, LLC II Sep-06-2022
3 BALT USA, LLC II Feb-22-2022
4 Codman & Shurtleff Inc II Aug-15-2019
5 Micro Therapeutics, Inc. II Jun-13-2022
6 Microvention, Inc. II Feb-27-2020
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