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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, continuous flush
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABLATIVE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGILE DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
BEND IT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALLISYN BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTWISE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR INSIGHTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VVT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 416 416
2017 537 537
2018 434 434
2019 418 418
2020 381 381
2021 440 440
2022 543 543
2023 828 828
2024 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Break 869 869
Adverse Event Without Identified Device or Use Problem 726 726
Physical Resistance/Sticking 587 587
Leak/Splash 204 204
Material Separation 194 194
Fracture 182 182
Material Deformation 169 169
Detachment of Device or Device Component 166 166
Burst Container or Vessel 133 133
Difficult to Remove 132 132
Device Dislodged or Dislocated 115 115
Physical Resistance 111 111
Material Integrity Problem 98 98
Device Damaged by Another Device 89 89
Entrapment of Device 89 89
Device Displays Incorrect Message 86 86
Difficult to Advance 82 82
Aspiration Issue 81 81
Obstruction of Flow 75 75
Detachment Of Device Component 61 61
Material Twisted/Bent 49 49
Material Perforation 46 46
Fluid/Blood Leak 45 45
Stretched 41 41
Kinked 33 33
Failure to Advance 32 32
Packaging Problem 32 32
Material Puncture/Hole 30 30
Fitting Problem 29 29
Defective Device 27 27
Deformation Due to Compressive Stress 27 27
No Apparent Adverse Event 27 27
Device Alarm System 27 27
Material Rupture 26 26
Difficult to Open or Remove Packaging Material 26 26
Device Damaged Prior to Use 24 24
Peeled/Delaminated 22 22
Electrical /Electronic Property Problem 18 18
Audible Prompt/Feedback Problem 18 18
Device Operates Differently Than Expected 17 17
Device Contamination with Chemical or Other Material 16 16
Difficult to Flush 16 16
Crack 16 16
Device Inoperable 15 15
Contamination /Decontamination Problem 15 15
Appropriate Term/Code Not Available 14 14
Collapse 14 14
Display or Visual Feedback Problem 14 14
Device Fell 14 14
Device Handling Problem 13 13
Suction Problem 13 13
Compatibility Problem 12 12
Hole In Material 12 12
Difficult to Insert 12 12
Occlusion Within Device 12 12
Output Problem 11 11
Positioning Problem 10 10
Insufficient Information 10 10
Delamination 10 10
Unintended Movement 10 10
Material Split, Cut or Torn 9 9
Temperature Problem 9 9
Device Difficult to Setup or Prepare 8 8
Sticking 8 8
Material Frayed 7 7
Flaked 7 7
Contamination 7 7
Device Markings/Labelling Problem 7 7
Separation Problem 7 7
Tear, Rip or Hole in Device Packaging 6 6
Electrical Shorting 6 6
Device Contaminated During Manufacture or Shipping 6 6
Material Fragmentation 6 6
Use of Device Problem 6 6
Unsealed Device Packaging 6 6
Migration or Expulsion of Device 6 6
Split 5 5
Activation, Positioning or Separation Problem 5 5
Connection Problem 4 4
Device Packaging Compromised 4 4
Component Missing 4 4
Material Too Soft/Flexible 4 4
Failure to Prime 4 4
Bent 4 4
Partial Blockage 4 4
Disconnection 3 3
Positioning Failure 3 3
Incorrect Measurement 3 3
Mechanical Problem 3 3
Melted 3 3
Unable to Obtain Readings 3 3
Unraveled Material 3 3
Radiation Underexposure 3 3
Torn Material 3 3
Mechanical Jam 3 3
Infusion or Flow Problem 3 3
Separation Failure 3 3
Difficult or Delayed Activation 3 3
Device Or Device Fragments Location Unknown 3 3
Cut In Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1318 1318
No Consequences Or Impact To Patient 889 889
No Known Impact Or Consequence To Patient 600 600
Intracranial Hemorrhage 196 196
Foreign Body In Patient 193 193
No Patient Involvement 146 146
Insufficient Information 111 111
Hemorrhage/Bleeding 109 109
Device Embedded In Tissue or Plaque 104 104
No Code Available 76 76
Stroke/CVA 68 68
Vasoconstriction 63 63
Unspecified Nervous System Problem 58 58
Hematoma 49 49
Thromboembolism 47 47
Obstruction/Occlusion 46 46
Thrombosis/Thrombus 44 44
Vascular Dissection 42 42
Death 41 41
Ischemia 40 40
Rupture 38 38
Perforation of Vessels 35 35
Ischemia Stroke 34 34
Paresis 33 33
Perforation 33 33
Swelling/ Edema 32 32
Embolism/Embolus 32 32
Stenosis 31 31
Pain 27 27
Vascular System (Circulation), Impaired 26 26
Thrombosis 21 21
Headache 21 21
Muscle Weakness 19 19
Fistula 18 18
Dysphasia 18 18
Thrombus 17 17
Pseudoaneurysm 17 17
Unspecified Infection 16 16
Paralysis 15 15
Hydrocephalus 15 15
Convulsion/Seizure 15 15
Blood Loss 14 14
Neurological Deficit/Dysfunction 14 14
Low Blood Pressure/ Hypotension 14 14
Visual Disturbances 13 13
No Information 13 13
Transient Ischemic Attack 12 12
Failure of Implant 12 12
Cardiac Arrest 12 12
Pulmonary Embolism 12 12
Bradycardia 12 12
Infarction, Cerebral 11 11
Renal Failure 11 11
Coma 11 11
Aneurysm 10 10
Arrhythmia 10 10
Dyspnea 9 9
Hemorrhage, Subarachnoid 9 9
Nausea 9 9
Nerve Damage 9 9
Cognitive Changes 9 9
Confusion/ Disorientation 9 9
Visual Impairment 8 8
Embolism 8 8
Loss of Vision 7 7
Respiratory Failure 7 7
Unintended Radiation Exposure 7 7
Heart Failure/Congestive Heart Failure 7 7
Respiratory Insufficiency 7 7
Ruptured Aneurysm 6 6
Dizziness 6 6
Blurred Vision 6 6
Chest Pain 6 6
Foreign Body Reaction 6 6
Hypersensitivity/Allergic reaction 6 6
High Blood Pressure/ Hypertension 6 6
Hemoptysis 5 5
Fatigue 5 5
Fever 5 5
Abdominal Pain 5 5
Sepsis 5 5
Skin Discoloration 5 5
Radiation Exposure, Unintended 5 5
Nervous System Injury 4 4
Hemorrhagic Stroke 4 4
Occlusion 4 4
Vomiting 4 4
Therapeutic Response, Decreased 4 4
Post Operative Wound Infection 4 4
Aspiration/Inhalation 4 4
Atrial Fibrillation 4 4
Cardiopulmonary Arrest 4 4
Encephalopathy 4 4
Hemorrhage, Cerebral 4 4
Inflammation 3 3
Hemolysis 3 3
Anemia 3 3
Bacterial Infection 3 3
Abscess 3 3
Paraplegia 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Feb-07-2024
2 Boston Scientific Corporation II Dec-17-2020
3 Cook Inc. I Dec-09-2019
4 Cook Inc. II Mar-02-2017
5 EKOS Corporation II Sep-21-2016
6 EKOS Corporation II Feb-24-2016
7 Merit Medical Systems, Inc. II Jan-02-2024
8 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
9 Micro Therapeutics, Inc. II Aug-18-2022
10 Sequent Medical Inc II Oct-27-2016
11 Vascular Insights, LLC II Mar-21-2018
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