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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 2
AGILE DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K202366  MAGIC Infusion Catheter
  2.  K213435  MAGIC Flow-Dependent Microcatheter
BEND IT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALLISYN BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2014 275 275
2015 338 338
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 957 957
Adverse Event Without Identified Device or Use Problem 788 788
Physical Resistance/Sticking 587 587
Material Separation 235 235
Leak/Splash 222 222
Fracture 218 218
Detachment of Device or Device Component 173 173
Material Deformation 171 171
Physical Resistance 170 170
Burst Container or Vessel 152 152
Difficult to Remove 150 150
Obstruction of Flow 144 144
Entrapment of Device 121 121
Device Dislodged or Dislocated 120 120
Material Integrity Problem 106 106
Device Damaged by Another Device 90 90
Difficult to Advance 90 90
Device Displays Incorrect Message 90 90
Detachment Of Device Component 85 85
Aspiration Issue 83 83
Device Damaged Prior to Use 68 68
Fluid/Blood Leak 52 52
Material Twisted/Bent 49 49
Material Perforation 47 47
Stretched 46 46
Material Rupture 46 46
Kinked 45 45
Failure to Advance 42 42
Material Puncture/Hole 34 34
Packaging Problem 33 33
No Apparent Adverse Event 31 31
Peeled/Delaminated 30 30
Fitting Problem 29 29
Deformation Due to Compressive Stress 28 28
Difficult to Open or Remove Packaging Material 28 28
Defective Device 27 27
Hole In Material 27 27
Device Alarm System 27 27
Device Operates Differently Than Expected 25 25
Device Contamination with Chemical or Other Material 22 22
Crack 21 21
Occlusion Within Device 21 21
Electrical /Electronic Property Problem 18 18
Audible Prompt/Feedback Problem 18 18
Inflation Problem 17 17
Device Inoperable 17 17
Material Fragmentation 16 16
Difficult to Flush 16 16
Collapse 15 15
Contamination /Decontamination Problem 15 15
Insufficient Information 15 15
Appropriate Term/Code Not Available 15 15
Device Fell 14 14
Positioning Problem 14 14
Display or Visual Feedback Problem 14 14
Difficult to Insert 13 13
Compatibility Problem 13 13
Suction Problem 13 13
Unintended Movement 13 13
Device Handling Problem 13 13
Component Missing 11 11
Output Problem 11 11
Delamination 10 10
Sticking 9 9
Material Frayed 9 9
Deflation Problem 9 9
Temperature Problem 9 9
Material Split, Cut or Torn 9 9
Torn Material 8 8
Migration or Expulsion of Device 8 8
Device Difficult to Setup or Prepare 8 8
Device Markings/Labelling Problem 8 8
Use of Device Problem 7 7
Mechanical Problem 7 7
Flaked 7 7
Contamination 7 7
Separation Problem 7 7
Bent 6 6
Unsealed Device Packaging 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Or Device Fragments Location Unknown 6 6
Split 6 6
Electrical Shorting 6 6
Device Contaminated During Manufacture or Shipping 6 6
Improper Flow or Infusion 5 5
Activation, Positioning or Separation Problem 5 5
Device Packaging Compromised 5 5
Disconnection 5 5
Component Falling 5 5
Flushing Problem 4 4
Partial Blockage 4 4
Positioning Failure 4 4
Failure to Prime 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Infusion or Flow Problem 4 4
Connection Problem 4 4
Unraveled Material 4 4
Material Too Soft/Flexible 4 4
Radiation Underexposure 3 3
Separation Failure 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 1170 1170
No Known Impact Or Consequence To Patient 718 718
No Patient Involvement 211 211
Foreign Body In Patient 205 205
Intracranial Hemorrhage 198 198
Device Embedded In Tissue or Plaque 139 139
Hemorrhage/Bleeding 116 116
Insufficient Information 111 111
No Code Available 88 88
Stroke/CVA 71 71
Vasoconstriction 69 69
Unspecified Nervous System Problem 58 58
Death 54 54
Hematoma 51 51
Thromboembolism 49 49
Vascular Dissection 47 47
Obstruction/Occlusion 46 46
Thrombosis/Thrombus 44 44
Rupture 40 40
Ischemia 40 40
Perforation of Vessels 37 37
Paresis 35 35
Perforation 34 34
Ischemia Stroke 34 34
Embolism/Embolus 32 32
Swelling/ Edema 32 32
Stenosis 32 32
No Information 30 30
Pain 29 29
Thrombosis 29 29
Vascular System (Circulation), Impaired 26 26
Thrombus 25 25
Headache 21 21
Muscle Weakness 19 19
Low Blood Pressure/ Hypotension 19 19
Fistula 18 18
Bradycardia 18 18
Dysphasia 18 18
Pseudoaneurysm 17 17
Unspecified Infection 16 16
Paralysis 15 15
Neurological Deficit/Dysfunction 15 15
Hydrocephalus 15 15
Convulsion/Seizure 15 15
Blood Loss 14 14
Pulmonary Embolism 14 14
Dyspnea 14 14
Visual Disturbances 13 13
Renal Failure 12 12
Transient Ischemic Attack 12 12
Infarction, Cerebral 12 12
Cardiac Arrest 12 12
Aneurysm 12 12
Failure of Implant 12 12
Hemorrhage, Subarachnoid 12 12
Embolism 11 11
Coma 11 11
Arrhythmia 10 10
Nausea 9 9
Nerve Damage 9 9
Cognitive Changes 9 9
Confusion/ Disorientation 9 9
Visual Impairment 8 8
Loss of Vision 8 8
Abdominal Pain 7 7
Chest Pain 7 7
Hypersensitivity/Allergic reaction 7 7
Respiratory Failure 7 7
Heart Failure/Congestive Heart Failure 7 7
Respiratory Insufficiency 7 7
Unintended Radiation Exposure 7 7
Ruptured Aneurysm 6 6
Radiation Exposure, Unintended 6 6
High Blood Pressure/ Hypertension 6 6
Foreign Body Reaction 6 6
Hemorrhage, Cerebral 6 6
Dizziness 6 6
Occlusion 6 6
Blurred Vision 6 6
Sepsis 5 5
Skin Discoloration 5 5
Numbness 5 5
Fatigue 5 5
Fever 5 5
Hemoptysis 5 5
Intimal Dissection 5 5
Aspiration/Inhalation 4 4
Atrial Fibrillation 4 4
Cardiopulmonary Arrest 4 4
Encephalopathy 4 4
Edema 4 4
Hemorrhage, Subdural 4 4
Post Operative Wound Infection 4 4
Foreign body, removal of 4 4
Vomiting 4 4
Therapeutic Response, Decreased 4 4
Swelling 4 4
Nervous System Injury 4 4
Hemorrhagic Stroke 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Feb-07-2024
2 Angiodynamics, Inc. II Aug-18-2014
3 Boston Scientific Corporation II Dec-17-2020
4 Cook Inc. I Dec-09-2019
5 Cook Inc. II Mar-02-2017
6 Cook Inc. II Nov-06-2015
7 Covidien I Feb-03-2015
8 EKOS Corporation II Sep-21-2016
9 EKOS Corporation II Feb-24-2016
10 EKOS Corporation II Jul-20-2015
11 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
12 Merit Medical Systems, Inc. II Jan-02-2024
13 Merit Medical Systems, Inc. II Oct-31-2014
14 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
15 Micro Therapeutics, Inc. II Aug-18-2022
16 Sequent Medical Inc II Oct-27-2016
17 Vascular Insights, LLC II Mar-21-2018
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