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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
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 163 163
2016 154 154
2017 115 115
2018 133 133
2019 144 144
2020 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 82 82
Deflation Problem 78 78
Material Rupture 75 75
Inflation Problem 68 68
Pacing Problem 66 66
Balloon 65 65
Appropriate Term/Code Not Available 47 47
Adverse Event Without Identified Device or Use Problem 44 44
Leak/Splash 29 29
Catheter 26 26
Incorrect Measurement 23 23
Break 21 21
Burst Container or Vessel 17 17
Detachment Of Device Component 17 17
Physical Resistance/Sticking 14 14
Fluid Leak 14 14
Display or Visual Feedback Problem 13 13
Failure to Capture 13 13
Difficult to Advance 12 12
Device Operates Differently Than Expected 11 11
Tip 10 10
No Pacing 10 10
No Device Output 9 9
Activation, Positioning or SeparationProblem 8 8
Detachment of Device or Device Component 7 7
Component Missing 7 7
Output Problem 7 7
Material Separation 7 7
Difficult to Remove 7 7
Device Contamination with Chemical or Other Material 6 6
Connection Problem 6 6
Material Integrity Problem 6 6
Entrapment of Device 6 6
Kinked 6 6
Defective Component 6 6
Unable to Obtain Readings 5 5
Material Puncture/Hole 5 5
Material Fragmentation 5 5
Defective Device 5 5
Failure to Calibrate 5 5
Material Twisted/Bent 4 4
Temperature Problem 4 4
Air Leak 4 4
Occlusion Within Device 4 4
Wire 4 4
Device Displays Incorrect Message 4 4
Unintended Movement 4 4
Activation Failure 3 3
Material Deformation 3 3
Flaked 3 3
Difficult to Insert 3 3
Disconnection 3 3
High Test Results 3 3
Low Test Results 3 3
Cable, Electrical 3 3
Mechanical Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Dislodged or Dislocated 3 3
Gas Leak 3 3
Patient-Device Incompatibility 2 2
Cut In Material 2 2
Incorrect Or Inadequate Test Results 2 2
Structural Problem 2 2
Failure to Sense 2 2
Material Split, Cut or Torn 2 2
Insufficient Information 2 2
Bent 2 2
Difficult To Position 2 2
Use of Device Problem 2 2
High Readings 2 2
Device Damaged Prior to Use 2 2
Product Quality Problem 2 2
Knotted 2 2
Port 2 2
Syringe 2 2
Device Alarm System 2 2
Failure to Advance 2 2
Data Problem 2 2
Device Markings/Labelling Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Device Sensing Problem 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Backflow 1 1
Difficult or Delayed Positioning 1 1
Accessory Incompatible 1 1
Loose or Intermittent Connection 1 1
Increase in Pressure 1 1
Device Difficult to Program or Calibrate 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Insufficient Flow or Under Infusion 1 1
Device Contamination with Body Fluid 1 1
Low Readings 1 1
Material Perforation 1 1
Retraction Problem 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 367 367
No Known Impact Or Consequence To Patient 243 245
No Patient Involvement 23 23
Vascular Dissection 18 18
No Code Available 17 17
Death 13 13
Arrhythmia 11 11
Device Embedded In Tissue or Plaque 9 10
No Information 9 9
Complaint, Ill-Defined 7 7
Pericardial Effusion 7 7
Thrombus 6 6
Perforation of Vessels 6 6
Foreign Body In Patient 6 6
Cardiac Arrest 6 6
Hemorrhage/Bleeding 6 6
Low Blood Pressure/ Hypotension 5 5
Cardiac Tamponade 5 5
High Blood Pressure/ Hypertension 3 3
Aortic Valve Stenosis 3 3
Chest Pain 3 3
Bradycardia 3 3
Atrial Fibrillation 2 2
Edema 2 2
Unspecified Infection 2 2
Pain 2 2
Cardiac Perforation 2 2
Hemoptysis 2 2
Dyskinesia 2 2
Myocardial Infarction 2 2
Great Vessel Perforation 2 2
Tingling 2 2
Pulmonary Embolism 2 2
Perforation 2 2
Pulmonary Valve Stenosis 2 2
Renal Failure 2 2
Septic Shock 1 1
Therapeutic Effects, Unexpected 1 1
Air Embolism 1 1
Anemia 1 1
Aneurysm 1 1
Atrial Flutter 1 1
Autoimmune Reaction 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Fever 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Rupture 1 1
Loss of consciousness 1 1
Skin Tears 1 1
Complete Heart Block 1 1
Paresis 1 1
Necrosis 1 1
Reaction 1 1
Injury 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Valvular Stenosis 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

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Dec-19-2019
2 Edwards Lifesciences, LLC I Jan-31-2019
3 Edwards Lifesciences, LLC II Jun-02-2015
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