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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
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABK BIOMEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
ARTIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213200  Solus Gold Embolization Device
ARTVENTIVE MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAIT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIC ACCELERATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
KA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SHAPE MEMORY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1185 1185
2020 1167 1167
2021 1444 1444
2022 1498 1498
2023 1374 1374
2024 402 402

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1539 1539
Detachment of Device or Device Component 1287 1287
Stretched 851 851
Adverse Event Without Identified Device or Use Problem 686 686
Physical Resistance/Sticking 662 662
Failure to Advance 475 475
Break 379 379
Premature Separation 372 372
Entrapment of Device 354 354
Migration 294 294
Difficult to Advance 278 278
Material Deformation 235 235
Premature Activation 189 189
Positioning Problem 182 182
Material Twisted/Bent 172 172
Difficult to Remove 169 169
Deformation Due to Compressive Stress 167 167
Migration or Expulsion of Device 144 144
Unraveled Material 131 131
Material Separation 91 91
Device Difficult to Setup or Prepare 86 86
Off-Label Use 79 79
Device-Device Incompatibility 70 70
Unintended Movement 70 70
Material Integrity Problem 68 68
Patient Device Interaction Problem 62 62
Packaging Problem 54 54
Difficult or Delayed Separation 52 52
Material Protrusion/Extrusion 50 50
Malposition of Device 50 50
Inadequacy of Device Shape and/or Size 47 47
Fracture 42 42
Activation, Positioning or Separation Problem 41 41
Difficult or Delayed Positioning 40 40
Positioning Failure 39 39
Material Rupture 35 35
Activation Problem 31 31
Difficult to Insert 30 30
Use of Device Problem 27 27
Product Quality Problem 26 26
Material Split, Cut or Torn 25 25
Improper or Incorrect Procedure or Method 24 24
Separation Problem 22 22
No Apparent Adverse Event 20 20
Therapy Delivered to Incorrect Body Area 19 19
Retraction Problem 18 18
Component Missing 18 18
Human-Device Interface Problem 18 18
Activation Failure 16 16
Difficult to Fold, Unfold or Collapse 15 15
Device Dislodged or Dislocated 12 12
Contamination 11 11
Display or Visual Feedback Problem 10 10
Device Markings/Labelling Problem 10 10
Device Contaminated During Manufacture or Shipping 10 10
Appropriate Term/Code Not Available 9 9
Incomplete or Missing Packaging 9 9
Obstruction of Flow 9 9
Leak/Splash 9 9
Material Fragmentation 8 8
Unintended Ejection 8 8
Fluid/Blood Leak 8 8
Defective Device 8 8
Device Damaged by Another Device 7 7
Poor Quality Image 7 7
Mechanical Problem 6 6
Crack 5 5
Insufficient Information 5 5
Compatibility Problem 4 4
Contamination /Decontamination Problem 4 4
Biocompatibility 4 4
Tear, Rip or Hole in Device Packaging 4 4
Failure to Disconnect 3 3
Expulsion 3 3
Device Contamination with Chemical or Other Material 3 3
Difficult to Open or Remove Packaging Material 3 3
Nonstandard Device 3 3
Unsealed Device Packaging 3 3
Delivered as Unsterile Product 2 2
Clumping in Device or Device Ingredient 2 2
Electrical /Electronic Property Problem 2 2
Connection Problem 2 2
Patient-Device Incompatibility 2 2
Expiration Date Error 2 2
Peeled/Delaminated 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Misassembled 2 2
Failure to Eject 2 2
Firing Problem 1 1
Material Too Soft/Flexible 1 1
Inaccurate Information 1 1
Poor Visibility 1 1
Misassembly by Users 1 1
Defective Component 1 1
Difficult or Delayed Activation 1 1
Device Tipped Over 1 1
Component or Accessory Incompatibility 1 1
Material Discolored 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3982 3982
No Consequences Or Impact To Patient 1078 1079
No Known Impact Or Consequence To Patient 755 755
Aneurysm 247 247
No Code Available 134 134
Foreign Body In Patient 123 123
Insufficient Information 95 95
Thromboembolism 72 72
Hemorrhage/Bleeding 54 54
Pain 51 51
Device Embedded In Tissue or Plaque 50 50
Obstruction/Occlusion 49 49
Stroke/CVA 47 47
Intracranial Hemorrhage 46 46
Ruptured Aneurysm 45 45
Thrombosis/Thrombus 45 45
Ischemia Stroke 39 39
Embolism/Embolus 37 37
Death 37 37
Vasoconstriction 35 35
Infarction, Cerebral 28 28
Hematoma 24 24
Ischemia 23 23
Perforation of Vessels 21 21
Hypersensitivity/Allergic reaction 20 20
No Patient Involvement 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Patient Problem/Medical Problem 18 18
Necrosis 18 18
Sepsis 18 18
Abdominal Pain 17 17
Fever 16 16
Therapeutic Response, Decreased 15 15
Pseudoaneurysm 15 15
Low Blood Pressure/ Hypotension 14 14
Convulsion/Seizure 14 14
Unspecified Infection 13 13
Rupture 13 13
Stenosis 12 12
Inflammation 12 12
Abscess 12 12
Hydrocephalus 12 12
Foreign Body Embolism 12 12
Swelling/ Edema 11 11
Unspecified Tissue Injury 11 11
Cardiac Arrest 11 11
Embolism 11 11
Vomiting 10 10
Thrombosis 10 10
Cardiac Tamponade 9 9
Renal Failure 9 9
Arrhythmia 9 9
Failure of Implant 9 9
High Blood Pressure/ Hypertension 9 9
Hemorrhage, Subarachnoid 9 9
Pancreatitis 9 9
Heart Failure/Congestive Heart Failure 8 8
Vascular Dissection 8 8
Muscle Weakness 8 8
Neurological Deficit/Dysfunction 8 8
Chest Pain 8 8
Tachycardia 8 8
Ascites 7 7
Autoimmune Disorder 7 7
Fatigue 7 7
Endocarditis 7 7
Nerve Damage 7 7
Headache 7 7
Myocardial Infarction 6 6
Liver Damage/Dysfunction 6 6
Encephalopathy 6 6
Sleep Dysfunction 6 6
Vascular System (Circulation), Impaired 6 6
Perforation 6 6
Pleural Effusion 6 6
Paresthesia 6 6
No Information 5 5
Pericardial Effusion 5 5
Gastrointestinal Hemorrhage 5 5
Paralysis 5 5
Pulmonary Edema 5 5
Shock 5 5
Transient Ischemic Attack 5 5
Cognitive Changes 5 5
Complaint, Ill-Defined 5 5
Numbness 5 5
Fistula 5 5
Anemia 5 5
Itching Sensation 5 5
Occlusion 5 5
Hair Loss 5 5
Hemolysis 4 4
Hemothorax 4 4
Nausea 4 4
Foreign Body Reaction 4 4
Arthralgia 4 4
Malaise 4 4
Dysphasia 4 4
Respiratory Failure 4 4
Chest Tightness/Pressure 4 4

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Feb-08-2024
2 Boston Scientific Corporation I Mar-27-2024
3 Cook Incorporated II Jun-06-2022
4 MICROVENTION INC. II Oct-27-2023
5 Microvention, Inc. II Feb-13-2020
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