• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, continuous flush
Regulation Description Continuous flush catheter.
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILE DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEND IT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
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
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
THROMBOLEX, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 537 537
2018 434 434
2019 418 418
2020 376 376
2021 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Break 510 510
Adverse Event Without Identified Device or Use Problem 259 259
Physical Resistance/Sticking 223 223
Material Separation 159 159
Fracture 94 94
Difficult to Remove 90 90
Detachment of Device or Device Component 86 86
Leak/Splash 79 79
Device Dislodged or Dislocated 77 77
Physical Resistance 74 74
Material Deformation 71 71
Entrapment of Device 62 62
Burst Container or Vessel 60 60
Material Integrity Problem 51 51
Device Damaged by Another Device 47 47
Detachment Of Device Component 44 44
Device Displays Incorrect Message 41 41
Fluid Leak 36 36
Material Perforation 35 35
Difficult to Advance 35 35
Aspiration Issue 35 35
Stretched 30 30
Fitting Problem 29 29
Obstruction of Flow 29 29
Kinked 28 28
Material Puncture/Hole 25 25
Device Alarm System 20 20
Failure to Advance 20 20
Material Twisted/Bent 19 19
Audible Prompt/Feedback Problem 18 18
Difficult to Open or Remove Packaging Material 15 15
Difficult to Flush 14 14
Material Rupture 14 14
Defective Device 13 13
Deformation Due to Compressive Stress 13 13
Device Contamination with Chemical or Other Material 13 13
Packaging Problem 12 12
Device Inoperable 12 12
Display or Visual Feedback Problem 11 11
Device Handling Problem 11 11
Device Operates Differently Than Expected 10 10
Crack 10 10
Suction Problem 10 10
Device Damaged Prior to Use 10 10
Peeled/Delaminated 10 10
Occlusion Within Device 9 9
Difficult to Insert 9 9
Contamination /Decontamination Problem 9 9
Electrical /Electronic Property Problem 8 8
Material Frayed 7 7
Sticking 7 7
Tear, Rip or Hole in Device Packaging 6 6
Device Difficult to Setup or Prepare 6 6
Hole In Material 6 6
Electrical Shorting 6 6
Positioning Problem 6 6
Material Split, Cut or Torn 6 6
Device Fell 6 6
Separation Problem 6 6
Insufficient Information 5 5
Temperature Problem 5 5
Output Problem 5 5
Connection Problem 4 4
Split 4 4
Appropriate Term/Code Not Available 4 4
No Apparent Adverse Event 4 4
Material Fragmentation 4 4
Contamination 4 4
Collapse 4 4
Bent 4 4
Failure to Prime 4 4
Unsealed Device Packaging 4 4
Component Missing 4 4
Cut In Material 3 3
Unraveled Material 3 3
Partial Blockage 3 3
Disconnection 3 3
Melted 3 3
Migration or Expulsion of Device 3 3
Torn Material 3 3
Radiation Underexposure 3 3
Difficult or Delayed Activation 3 3
Device Packaging Compromised 3 3
Mechanical Jam 3 3
Material Protrusion/Extrusion 2 2
Human-Device Interface Problem 2 2
Improper Flow or Infusion 2 2
Compatibility Problem 2 2
Infusion or Flow Problem 2 2
Device Markings/Labelling Problem 2 2
Delamination 2 2
Activation, Positioning or SeparationProblem 2 2
Unintended Movement 2 2
Sharp Edges 2 2
Incorrect Measurement 2 2
Positioning Failure 2 2
Use of Device Problem 2 2
Overheating of Device 2 2
Retraction Problem 2 2
Unable to Obtain Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 692 692
No Known Impact Or Consequence To Patient 488 488
No Clinical Signs, Symptoms or Conditions 319 319
Foreign Body In Patient 119 119
No Patient Involvement 115 115
Device Embedded In Tissue or Plaque 69 69
No Code Available 68 68
Intracranial Hemorrhage 56 56
Death 37 37
Insufficient Information 29 29
Vascular System (Circulation), Impaired 26 26
Hemorrhage/Bleeding 25 25
Perforation 22 22
Vasoconstriction 22 22
Thrombosis 17 17
Perforation of Vessels 17 17
Hematoma 17 17
Stroke/CVA 17 17
Thrombus 15 15
Blood Loss 12 12
Fistula 12 12
Bradycardia 11 11
Neurological Deficit/Dysfunction 11 11
Thromboembolism 11 11
Paresis 10 10
Pain 9 9
Pulmonary Embolism 9 9
No Information 9 9
Cardiac Arrest 8 8
Infarction, Cerebral 8 8
Dyspnea 8 8
Hemorrhage, Subarachnoid 8 8
Low Blood Pressure/ Hypotension 8 8
Ischemia 6 6
Paralysis 6 6
Renal Failure 6 6
Arrhythmia 6 6
Vascular Dissection 6 6
Obstruction/Occlusion 6 6
Unspecified Nervous System Problem 6 6
Embolism/Embolus 6 6
Hydrocephalus 6 6
Thrombosis/Thrombus 5 5
Radiation Exposure, Unintended 5 5
Embolism 5 5
Hemoptysis 5 5
Nausea 5 5
Occlusion 4 4
Muscle Weakness 4 4
Unspecified Infection 4 4
Headache 4 4
Aneurysm 4 4
Chest Pain 4 4
Stenosis 4 4
Rupture 3 3
Dysphasia 3 3
Blurred Vision 3 3
Vomiting 3 3
Respiratory Failure 3 3
Ischemia Stroke 3 3
Swelling/ Edema 3 3
Cardiopulmonary Arrest 3 3
Abdominal Pain 3 3
Foreign Body Reaction 3 3
Hemorrhage, Cerebral 3 3
High Blood Pressure/ Hypertension 3 3
Sepsis 3 3
Swelling 2 2
Hemorrhage, Subdural 2 2
Hemothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Edema 2 2
Fever 2 2
Hemolysis 2 2
Vessel Or Plaque, Device Embedded In 2 2
Intimal Dissection 2 2
Anemia 2 2
Aspiration/Inhalation 2 2
Atrial Fibrillation 2 2
Missing Value Reason 2 2
Multiple Organ Failure 2 2
Missed Dose 2 2
Pseudoaneurysm 2 2
Loss of Vision 2 2
Therapeutic Response, Decreased 2 2
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Ventilator Dependent 1 1
Brain Injury 1 1
Dizziness 1 1
Visual Impairment 1 1
Tissue Damage 1 1
Ventricular Tachycardia 1 1
Dysuria 1 1
Chemical Exposure 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1

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 Vascular Insights, LLC II Mar-21-2018
-
-