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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
Regulation Description Continuous flush catheter.
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERCATOR MEDSYSTEMS,
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR INSIGHTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 338 338
2016 416 416
2017 537 537
2018 433 433
2019 418 418
2020 261 261

Device Problems MDRs with this Device Problem Events in those MDRs
Break 539 539
Catheter 422 422
Adverse Event Without Identified Device or Use Problem 221 221
Material Separation 160 160
Fracture 143 143
Physical Resistance 139 139
Physical Resistance/Sticking 121 121
Difficult to Remove 99 99
Aspiration Issue 83 83
Device Dislodged or Dislocated 82 82
Device Displays Incorrect Message 79 79
Detachment Of Device Component 76 76
Burst Container or Vessel 74 74
Leak/Splash 73 73
Entrapment of Device 72 72
Detachment of Device or Device Component 70 70
Tip 70 70
Obstruction of Flow 64 64
Shaft 56 56
Device Damaged Prior to Use 50 50
Material Deformation 50 50
Device Damaged by Another Device 50 50
Kinked 40 40
Material Integrity Problem 31 31
Fluid Leak 31 31
Material Perforation 30 30
Difficult to Advance 30 30
Fitting Problem 29 29
Material Rupture 26 26
Material Puncture/Hole 25 25
Device Operates Differently Than Expected 24 24
Stretched 23 23
Failure to Advance 23 23
Guidewire 22 22
Hub 21 21
Peeled/Delaminated 21 21
Hole In Material 21 21
Balloon 19 19
Audible Prompt/Feedback Problem 18 18
Occlusion Within Device 17 17
Device Inoperable 16 16
Device Contamination with Chemical or Other Material 16 16
Deformation Due to Compressive Stress 16 16
Crack 13 13
Device Handling Problem 13 13
Insufficient Information 11 11
Wire 11 11
Delamination 10 10
Difficult to Open or Remove Packaging Material 10 10
Material Twisted/Bent 9 9
Defective Device 9 9
Display or Visual Feedback Problem 9 9
Inflation Problem 9 9
Appropriate Term/Code Not Available 9 9
Difficult to Insert 9 9
Sticking 8 8
Positioning Problem 8 8
Contamination /Decontamination Problem 7 7
Flaked 7 7
Packaging Problem 7 7
Material Fragmentation 7 7
Component Missing 7 7
Split 6 6
Mechanical Problem 6 6
Device Alarm System 6 6
Electrical Shorting 6 6
Component Falling 5 5
Bent 5 5
Deflation Problem 5 5
Device Packaging Compromised 5 5
Device Or Device Fragments Location Unknown 5 5
Suction Problem 5 5
Material Split, Cut or Torn 5 5
Torn Material 4 4
Separation Problem 4 4
Use of Device Problem 4 4
Difficult to Flush 4 4
Flushing Problem 4 4
Device Difficult to Setup or Prepare 4 4
Migration or Expulsion of Device 4 4
Tear, Rip or Hole in Device Packaging 4 4
Partial Blockage 4 4
Material Frayed 4 4
Unraveled Material 3 3
Unable to Obtain Readings 3 3
Disconnection 3 3
Electrical /Electronic Property Problem 3 3
Coil 3 3
Port 3 3
Connection Problem 3 3
Device Markings/Labelling Problem 3 3
Difficult or Delayed Activation 3 3
Radiation Underexposure 3 3
Failure to Prime 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Melted 3 3
Positioning Failure 3 3
Cut In Material 3 3
Improper Flow or Infusion 3 3
No Apparent Adverse Event 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 959 959
No Known Impact Or Consequence To Patient 658 658
No Patient Involvement 174 174
Foreign Body In Patient 126 126
Device Embedded In Tissue or Plaque 87 87
No Code Available 72 72
Death 43 43
Intracranial Hemorrhage 27 27
Vascular System (Circulation), Impaired 26 26
Thrombosis 23 23
Vasoconstriction 22 22
Perforation 22 22
No Information 21 21
Hemorrhage/Bleeding 19 19
Perforation of Vessels 19 19
Thrombus 18 18
Bradycardia 16 16
Neurological Deficit/Dysfunction 15 15
Hematoma 12 12
Hemorrhage, Subarachnoid 12 12
Blood Loss 12 12
Infarction, Cerebral 11 11
Low Blood Pressure/ Hypotension 11 11
Paresis 11 11
Vascular Dissection 11 11
Pulmonary Embolism 10 10
Fistula 10 10
Pain 10 10
Embolism 9 9
Dyspnea 9 9
Renal Failure 7 7
Hemorrhage, Cerebral 6 6
Radiation Exposure, Unintended 6 6
Hemoptysis 5 5
Occlusion 5 5
Ischemia 4 4
Rupture 4 4
Cardiopulmonary Arrest 4 4
Cardiac Arrest 4 4
Stroke/CVA 4 4
Intimal Dissection 4 4
Thromboembolism 4 4
Therapeutic Response, Decreased 4 4
Stenosis 3 3
Abdominal Pain 3 3
Arrhythmia 3 3
Foreign Body Reaction 3 3
Hemorrhage, Subdural 3 3
Aneurysm 3 3
Vessel Or Plaque, Device Embedded In 2 2
Hemorrhage, Intraventricular 2 2
Hypersensitivity/Allergic reaction 2 2
Fever 2 2
Sepsis 2 2
Swelling 2 2
Multiple Organ Failure 2 2
Foreign body, removal of 2 2
Respiratory Failure 2 2
Missed Dose 2 2
Edema 2 2
Headache 2 2
Hemolysis 2 2
Chest Pain 2 2
Atrial Fibrillation 2 2
Missing Value Reason 2 2
Hypoxia 2 2
Unspecified Infection 2 2
Nausea 2 2
Injury 2 2
Ventilator Dependent 1 1
Reaction 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
Nerve Proximity Nos (Not Otherwise Specified) 1 1
Necrosis 1 1
Nerve Damage 1 1
Overdose 1 1
Laceration(s) 1 1
Complaint, Ill-Defined 1 1
Syncope 1 1
Bruise/Contusion 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Ecchymosis 1 1
Embolus 1 1
Facial Nerve Paralysis 1 1
Hemothorax 1 1
Hyperventilation 1 1
Paralysis 1 1
Pulmonary Edema 1 1
Seizures 1 1
Tinnitus 1 1
Tissue Damage 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Vomiting 1 1
Great Vessel Perforation 1 1
Headache, Lumbar Puncture 1 1
Dizziness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. I Dec-09-2019
2 Cook Inc. II Mar-02-2017
3 Cook Inc. II Nov-06-2015
4 Covidien I Feb-03-2015
5 EKOS Corporation II Sep-21-2016
6 EKOS Corporation II Feb-24-2016
7 EKOS Corporation II Jul-20-2015
8 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
9 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
10 Sequent Medical Inc II Oct-27-2016
11 Vascular Insights, LLC II Mar-21-2018
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