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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, flow directed
Regulation Description Flow-directed catheter.
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 154 154
2017 115 115
2018 133 133
2019 144 144
2020 104 104
2021 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 88 88
Pacing Problem 78 78
Inflation Problem 67 67
Material Rupture 63 63
Incorrect Measurement 57 57
Deflation Problem 54 54
Adverse Event Without Identified Device or Use Problem 47 47
Appropriate Term/Code Not Available 42 42
Leak/Splash 23 23
Failure to Capture 23 23
Material Separation 21 21
Break 20 20
Burst Container or Vessel 14 14
Physical Resistance/Sticking 14 14
Difficult to Advance 13 13
No Pacing 11 11
Detachment of Device or Device Component 10 10
Fluid Leak 9 9
No Device Output 9 9
Difficult to Remove 8 8
Entrapment of Device 8 8
Detachment Of Device Component 7 7
Component Missing 7 7
Output Problem 7 7
Activation, Positioning or SeparationProblem 6 6
Device Operates Differently Than Expected 6 6
Material Puncture/Hole 6 6
Material Fragmentation 6 6
Difficult to Insert 6 6
Device Contamination with Chemical or Other Material 6 6
Material Integrity Problem 6 6
Material Deformation 5 5
Connection Problem 5 5
Kinked 5 5
Defective Device 5 5
Patient-Device Incompatibility 4 4
Temperature Problem 4 4
Material Twisted/Bent 4 4
Occlusion Within Device 4 4
Unable to Obtain Readings 4 4
Insufficient Flow or Under Infusion 4 4
Defective Component 4 4
Failure to Advance 4 4
Device Displays Incorrect Message 4 4
High Test Results 3 3
Disconnection 3 3
Flaked 3 3
Activation Failure 3 3
Unintended Movement 3 3
Insufficient Information 3 3
Gas Leak 3 3
Failure to Calibrate 3 3
Mechanical Problem 3 3
Use of Device Problem 2 2
Bent 2 2
Air Leak 2 2
Incorrect Or Inadequate Test Results 2 2
Structural Problem 2 2
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Split, Cut or Torn 2 2
Data Problem 2 2
Device Alarm System 2 2
Low Test Results 2 2
High Readings 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged Prior to Use 1 1
Low Readings 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Backflow 1 1
Coagulation in Device or Device Ingredient 1 1
Difficult or Delayed Positioning 1 1
Increase in Pressure 1 1
Device Difficult to Program or Calibrate 1 1
Knotted 1 1
Loose or Intermittent Connection 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inaccurate Information 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Infusion or Flow Problem 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Signal Artifact/Noise 1 1
Complete Blockage 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 403 403
No Known Impact Or Consequence To Patient 201 201
No Clinical Signs, Symptoms or Conditions 29 29
No Patient Involvement 24 24
Vascular Dissection 15 15
No Code Available 14 14
No Information 10 10
Arrhythmia 10 10
Death 9 9
Device Embedded In Tissue or Plaque 8 8
Foreign Body In Patient 6 6
Complaint, Ill-Defined 6 6
Hemorrhage/Bleeding 6 6
Thrombus 6 6
Perforation of Vessels 5 5
Cardiac Tamponade 5 5
Pericardial Effusion 5 5
Cardiac Arrest 5 5
Bradycardia 4 4
Cardiac Perforation 4 4
Low Blood Pressure/ Hypotension 4 4
Aortic Valve Stenosis 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 3 3
Great Vessel Perforation 3 3
Tingling 2 2
Myocardial Infarction 2 2
Dyskinesia 2 2
Reaction 2 2
Hemoptysis 2 2
Atrial Fibrillation 2 2
Edema 2 2
Chest Pain 2 2
Unspecified Infection 2 2
Pain 2 2
Dyspnea 2 2
Pulmonary Valve Stenosis 2 2
Renal Failure 2 2
Pulmonary Embolism 2 2
Insufficient Information 2 2
Anaphylactoid 2 2
Rupture 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Paresis 1 1
Perforation 1 1
Loss of consciousness 1 1
Skin Tears 1 1
Complete Heart Block 1 1
Air Embolism 1 1
Anemia 1 1
Aneurysm 1 1
Atrial Flutter 1 1
Autoimmune Reaction 1 1
Cardiopulmonary Arrest 1 1
Sepsis 1 1
Septic Shock 1 1
Therapeutic Effects, Unexpected 1 1
Non specific EKG/ECG Changes 1 1
Fever 1 1
Pneumothorax 1 1
Shock 1 1
Tissue Damage 1 1
Left Ventricular Dysfunction 1 1
Foreign Body Reaction 1 1
Headache 1 1
Exposure to Body Fluids 1 1
Anaphylactic Shock 1 1
Valvular Stenosis 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Injury 1 1
Necrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Dec-19-2019
2 Edwards Lifesciences, LLC I Jan-31-2019
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