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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
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 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
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 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  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
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 2
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 434 434
2019 418 418
2020 381 381
2021 439 439
2022 540 540
2023 217 217

Device Problems MDRs with this Device Problem Events in those MDRs
Break 530 530
Adverse Event Without Identified Device or Use Problem 424 424
Physical Resistance/Sticking 372 372
Material Separation 139 139
Detachment of Device or Device Component 121 121
Leak/Splash 104 104
Material Deformation 102 102
Fracture 90 90
Device Dislodged or Dislocated 78 78
Burst Container or Vessel 76 76
Difficult to Remove 66 66
Entrapment of Device 65 65
Material Integrity Problem 63 63
Device Damaged by Another Device 56 56
Difficult to Advance 53 53
Material Perforation 36 36
Fluid/Blood Leak 35 35
Obstruction of Flow 32 32
Material Twisted/Bent 32 32
Fitting Problem 28 28
Stretched 26 26
Difficult to Open or Remove Packaging Material 26 26
Physical Resistance 25 25
Defective Device 24 24
Material Puncture/Hole 23 23
Device Alarm System 23 23
Packaging Problem 20 20
No Apparent Adverse Event 19 19
Audible Prompt/Feedback Problem 18 18
Deformation Due to Compressive Stress 18 18
Failure to Advance 17 17
Difficult to Flush 15 15
Display or Visual Feedback Problem 14 14
Electrical /Electronic Property Problem 14 14
Device Fell 14 14
Suction Problem 12 12
Material Rupture 12 12
Contamination /Decontamination Problem 11 11
Crack 10 10
Detachment Of Device Component 10 10
Peeled/Delaminated 9 9
Compatibility Problem 9 9
Output Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Temperature Problem 8 8
Device Difficult to Setup or Prepare 8 8
Kinked 8 8
Collapse 8 8
Material Frayed 7 7
Difficult to Insert 7 7
Appropriate Term/Code Not Available 7 7
Material Split, Cut or Torn 6 6
Separation Problem 6 6
Electrical Shorting 6 6
Unsealed Device Packaging 6 6
Tear, Rip or Hole in Device Packaging 6 6
Contamination 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Markings/Labelling Problem 5 5
Unintended Movement 5 5
Insufficient Information 4 4
Positioning Problem 4 4
Migration or Expulsion of Device 4 4
Device Displays Incorrect Message 4 4
Occlusion Within Device 4 4
Incorrect Measurement 3 3
Hole In Material 3 3
Partial Blockage 3 3
Radiation Underexposure 3 3
Mechanical Jam 3 3
Difficult or Delayed Activation 3 3
Activation, Positioning or Separation Problem 3 3
Connection Problem 3 3
Device Packaging Compromised 3 3
Device-Device Incompatibility 2 2
Human-Device Interface Problem 2 2
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Too Soft/Flexible 2 2
Sharp Edges 2 2
Backflow 2 2
Mechanical Problem 2 2
Disconnection 2 2
Failure to Prime 2 2
Unable to Obtain Readings 2 2
Retraction Problem 2 2
Component Missing 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Aspiration Issue 1 1
Device Or Device Fragments Location Unknown 1 1
Split 1 1
Cut In Material 1 1
Structural Problem 1 1
Product Quality Problem 1 1
Smoking 1 1
Off-Label Use 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 801 801
No Consequences Or Impact To Patient 528 528
No Known Impact Or Consequence To Patient 320 320
Intracranial Hemorrhage 113 113
Foreign Body In Patient 96 96
No Patient Involvement 72 72
Insufficient Information 68 68
Device Embedded In Tissue or Plaque 68 68
Hemorrhage/Bleeding 58 58
No Code Available 55 55
Stroke/CVA 45 45
Vasoconstriction 45 45
Death 32 32
Thromboembolism 29 29
Hematoma 29 29
Thrombosis/Thrombus 28 28
Perforation of Vessels 27 27
Vascular System (Circulation), Impaired 26 26
Unspecified Nervous System Problem 26 26
Vascular Dissection 25 25
Obstruction/Occlusion 22 22
Embolism/Embolus 21 21
Ischemia 20 20
Stenosis 18 18
Swelling/ Edema 15 15
Rupture 14 14
Muscle Weakness 13 13
Thrombosis 12 12
Pain 12 12
Cardiac Arrest 11 11
Fistula 11 11
Low Blood Pressure/ Hypotension 11 11
Paresis 11 11
Bradycardia 11 11
Dysphasia 10 10
Renal Failure 10 10
Headache 10 10
Paralysis 10 10
Unspecified Infection 10 10
Blood Loss 10 10
Thrombus 9 9
Pseudoaneurysm 9 9
Arrhythmia 9 9
Hydrocephalus 8 8
Pulmonary Embolism 8 8
Unintended Radiation Exposure 7 7
Nausea 7 7
Dyspnea 7 7
Perforation 7 7
Aneurysm 6 6
Infarction, Cerebral 6 6
Loss of Vision 6 6
Neurological Deficit/Dysfunction 5 5
Respiratory Failure 5 5
Nerve Damage 5 5
Hemorrhage, Subarachnoid 5 5
Hemoptysis 5 5
Convulsion/Seizure 5 5
Ruptured Aneurysm 4 4
Sepsis 4 4
Heart Failure/Congestive Heart Failure 4 4
Atrial Fibrillation 4 4
High Blood Pressure/ Hypertension 4 4
Cognitive Changes 4 4
Transient Ischemic Attack 4 4
Blurred Vision 4 4
Respiratory Insufficiency 4 4
Myocardial Infarction 3 3
Hypersensitivity/Allergic reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fever 3 3
Cardiopulmonary Arrest 3 3
Chest Pain 3 3
Vomiting 3 3
Dizziness 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Ischemia Stroke 3 3
Aspiration/Inhalation 3 3
Hemorrhage, Cerebral 3 3
Confusion/ Disorientation 3 3
Abdominal Pain 3 3
Foreign Body Reaction 2 2
Multiple Organ Failure 2 2
Post Operative Wound Infection 2 2
Hemorrhagic Stroke 2 2
Hemothorax 2 2
Coma 2 2
Quadriplegia 2 2
Failure of Implant 2 2
Anemia 2 2
Cardiogenic Shock 2 2
Pneumonia 2 2
Coagulation Disorder 2 2
Embolism 2 2
Hematuria 2 2
Unspecified Vascular Problem 2 2
Visual Disturbances 2 2
Occlusion 2 2
Hypoxia 2 2
Hemolysis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-17-2020
2 Cook Inc. I Dec-09-2019
3 Micro Therapeutics, Inc. II Aug-18-2022
4 Vascular Insights, LLC II Mar-21-2018
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