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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
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 2
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 SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 1
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 537 537
2018 434 434
2019 418 418
2020 378 378
2021 437 437
2022 449 449

Device Problems MDRs with this Device Problem Events in those MDRs
Break 608 608
Adverse Event Without Identified Device or Use Problem 376 376
Physical Resistance/Sticking 298 298
Material Separation 169 169
Leak/Splash 107 107
Detachment of Device or Device Component 105 105
Fracture 102 102
Difficult to Remove 99 99
Device Dislodged or Dislocated 92 92
Material Deformation 92 92
Burst Container or Vessel 80 80
Physical Resistance 74 74
Entrapment of Device 72 72
Material Integrity Problem 61 61
Device Damaged by Another Device 56 56
Detachment Of Device Component 44 44
Difficult to Advance 43 43
Device Displays Incorrect Message 41 41
Fluid/Blood Leak 40 40
Material Perforation 38 38
Obstruction of Flow 36 36
Aspiration Issue 35 35
Stretched 33 33
Fitting Problem 29 29
Material Twisted/Bent 29 29
Material Puncture/Hole 28 28
Kinked 28 28
Difficult to Open or Remove Packaging Material 25 25
Failure to Advance 24 24
Device Alarm System 23 23
Defective Device 19 19
Audible Prompt/Feedback Problem 18 18
Deformation Due to Compressive Stress 17 17
Material Rupture 17 17
Packaging Problem 15 15
No Apparent Adverse Event 14 14
Difficult to Flush 14 14
Suction Problem 13 13
Peeled/Delaminated 13 13
Device Contamination with Chemical or Other Material 13 13
Device Inoperable 12 12
Display or Visual Feedback Problem 12 12
Electrical /Electronic Property Problem 11 11
Difficult to Insert 11 11
Device Handling Problem 11 11
Device Operates Differently Than Expected 10 10
Crack 10 10
Device Damaged Prior to Use 10 10
Occlusion Within Device 9 9
Contamination /Decontamination Problem 9 9
Device Fell 9 9
Positioning Problem 8 8
Temperature Problem 8 8
Output Problem 8 8
Compatibility Problem 8 8
Appropriate Term/Code Not Available 7 7
Device Difficult to Setup or Prepare 7 7
Sticking 7 7
Collapse 7 7
Material Frayed 7 7
Hole In Material 6 6
Material Split, Cut or Torn 6 6
Separation Problem 6 6
Electrical Shorting 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Markings/Labelling Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Insufficient Information 5 5
Contamination 5 5
Unsealed Device Packaging 5 5
Migration or Expulsion of Device 4 4
Failure to Prime 4 4
Component Missing 4 4
Bent 4 4
Material Fragmentation 4 4
Connection Problem 4 4
Split 4 4
Difficult or Delayed Activation 3 3
Cut In Material 3 3
Activation, Positioning or Separation Problem 3 3
Device Packaging Compromised 3 3
Torn Material 3 3
Unintended Movement 3 3
Mechanical Jam 3 3
Radiation Underexposure 3 3
Disconnection 3 3
Incorrect Measurement 3 3
Partial Blockage 3 3
Unraveled Material 3 3
Use of Device Problem 3 3
Melted 3 3
Overheating of Device 2 2
Unable to Obtain Readings 2 2
Retraction Problem 2 2
Backflow 2 2
Mechanical Problem 2 2
Positioning Failure 2 2
Sharp Edges 2 2
Material Protrusion/Extrusion 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 693 693
No Clinical Signs, Symptoms or Conditions 610 610
No Known Impact Or Consequence To Patient 488 488
Foreign Body In Patient 137 137
No Patient Involvement 116 116
Intracranial Hemorrhage 90 90
Device Embedded In Tissue or Plaque 79 79
No Code Available 68 68
Hemorrhage/Bleeding 49 49
Insufficient Information 48 48
Vasoconstriction 38 38
Death 37 37
Stroke/CVA 34 34
Vascular System (Circulation), Impaired 26 26
Perforation 25 25
Perforation of Vessels 24 24
Hematoma 24 24
Thrombosis/Thrombus 20 20
Thromboembolism 19 19
Thrombosis 17 17
Thrombus 15 15
Obstruction/Occlusion 14 14
Vascular Dissection 14 14
Unspecified Nervous System Problem 13 13
Embolism/Embolus 13 13
Fistula 13 13
Low Blood Pressure/ Hypotension 12 12
Pain 12 12
Paresis 12 12
Blood Loss 12 12
Swelling/ Edema 12 12
Neurological Deficit/Dysfunction 11 11
Bradycardia 11 11
Cardiac Arrest 10 10
Pulmonary Embolism 10 10
No Information 9 9
Pseudoaneurysm 8 8
Rupture 8 8
Stenosis 8 8
Renal Failure 8 8
Arrhythmia 8 8
Infarction, Cerebral 8 8
Dyspnea 8 8
Paralysis 8 8
Ischemia 8 8
Unspecified Infection 8 8
Hemorrhage, Subarachnoid 8 8
Headache 7 7
Muscle Weakness 6 6
Nausea 6 6
Aneurysm 6 6
Hydrocephalus 6 6
Unintended Radiation Exposure 5 5
Dysphasia 5 5
Radiation Exposure, Unintended 5 5
Respiratory Failure 5 5
Embolism 5 5
Hemoptysis 5 5
Occlusion 4 4
Hypersensitivity/Allergic reaction 4 4
High Blood Pressure/ Hypertension 4 4
Chest Pain 4 4
Abdominal Pain 4 4
Blurred Vision 4 4
Respiratory Insufficiency 4 4
Heart Failure/Congestive Heart Failure 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Ischemia Stroke 3 3
Sepsis 3 3
Cognitive Changes 3 3
Vomiting 3 3
Atrial Fibrillation 3 3
Cardiopulmonary Arrest 3 3
Foreign Body Reaction 3 3
Fever 3 3
Hemorrhage, Cerebral 3 3
Hemolysis 3 3
Hemorrhage, Subdural 2 2
Hemothorax 2 2
Inflammation 2 2
Hypoxia 2 2
Nerve Damage 2 2
Myocardial Infarction 2 2
Edema 2 2
Aspiration/Inhalation 2 2
Anemia 2 2
Vessel Or Plaque, Device Embedded In 2 2
Intimal Dissection 2 2
Therapeutic Response, Decreased 2 2
Hematuria 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Swelling 2 2
Hemorrhagic Stroke 2 2
Ruptured Aneurysm 2 2
Unspecified Vascular Problem 2 2
Missing Value Reason 2 2
Multiple Organ Failure 2 2
Missed Dose 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-17-2020
2 Cook Inc. I Dec-09-2019
3 Cook Inc. II Mar-02-2017
4 Micro Therapeutics, Inc. II Aug-18-2022
5 Vascular Insights, LLC II Mar-21-2018
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