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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
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 115 115
2018 133 133
2019 144 144
2020 104 104
2021 97 97
2022 130 130
2023 227 227
2024 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 137 137
Pacing Problem 91 91
Incorrect Measurement 87 87
Inflation Problem 86 86
Incorrect, Inadequate or Imprecise Result or Readings 84 84
Deflation Problem 75 75
Adverse Event Without Identified Device or Use Problem 54 54
Leak/Splash 47 47
Appropriate Term/Code Not Available 38 38
Failure to Capture 33 33
Difficult to Advance 32 32
Material Separation 28 28
Break 24 24
Burst Container or Vessel 23 23
Material Split, Cut or Torn 22 22
Physical Resistance/Sticking 22 22
Detachment of Device or Device Component 21 21
Difficult to Remove 16 16
No Pacing 15 15
Fluid/Blood Leak 15 15
Material Deformation 12 12
Material Puncture/Hole 12 12
No Device Output 11 11
Defective Device 9 9
Failure to Deflate 9 9
Component Missing 9 9
Difficult or Delayed Positioning 8 8
Material Integrity Problem 8 8
Unable to Obtain Readings 8 8
Difficult to Insert 8 8
Entrapment of Device 6 6
Output Problem 6 6
Detachment Of Device Component 6 6
Material Fragmentation 6 6
Material Twisted/Bent 6 6
Activation, Positioning or Separation Problem 6 6
Obstruction of Flow 6 6
Defective Component 5 5
Failure to Advance 5 5
Patient-Device Incompatibility 4 4
Therapeutic or Diagnostic Output Failure 4 4
Use of Device Problem 4 4
Connection Problem 4 4
Activation Failure 4 4
Inaccurate Information 4 4
Temperature Problem 4 4
Insufficient Information 4 4
Insufficient Flow or Under Infusion 4 4
Flaked 3 3
Malposition of Device 3 3
Mechanical Problem 3 3
Crack 3 3
Device Contamination with Chemical or Other Material 3 3
Unintended Movement 3 3
High Test Results 3 3
Device Displays Incorrect Message 3 3
Failure to Calibrate 3 3
Difficult to Flush 3 3
Gas/Air Leak 3 3
Contamination 3 3
Product Quality Problem 3 3
Tear, Rip or Hole in Device Packaging 2 2
Data Problem 2 2
Device Operates Differently Than Expected 2 2
Pacing Inadequately 2 2
Device Dislodged or Dislocated 2 2
Signal Artifact/Noise 2 2
Capturing Problem 2 2
High Readings 2 2
Air Leak 2 2
Complete Blockage 2 2
Material Protrusion/Extrusion 2 2
Separation Problem 2 2
Device Alarm System 2 2
Disconnection 2 2
Difficult or Delayed Activation 1 1
Loose or Intermittent Connection 1 1
Kinked 1 1
Device Markings/Labelling Problem 1 1
Device Damaged Prior to Use 1 1
Nonstandard Device 1 1
Inaccurate Delivery 1 1
Packaging Problem 1 1
Calibration Problem 1 1
Display or Visual Feedback Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Excess Flow or Over-Infusion 1 1
Off-Label Use 1 1
Pacing Intermittently 1 1
Protective Measures Problem 1 1
Unsealed Device Packaging 1 1
Unclear Information 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Pressure Problem 1 1
Low Test Results 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Difficult to Program or Calibrate 1 1
Backflow 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 400 400
No Consequences Or Impact To Patient 314 314
No Known Impact Or Consequence To Patient 165 165
Insufficient Information 54 54
No Patient Involvement 23 23
Vascular Dissection 15 15
No Code Available 13 13
Hemorrhage/Bleeding 13 13
Arrhythmia 11 11
Cardiac Tamponade 10 10
No Information 9 9
Foreign Body In Patient 8 8
Low Blood Pressure/ Hypotension 8 8
Death 7 7
Cardiac Perforation 7 7
Device Embedded In Tissue or Plaque 7 7
Great Vessel Perforation 7 7
Cardiac Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Bradycardia 5 5
Hypersensitivity/Allergic reaction 4 4
Pain 4 4
Needle Stick/Puncture 4 4
Complaint, Ill-Defined 3 3
Perforation of Vessels 3 3
Pericardial Effusion 3 3
High Blood Pressure/ Hypertension 3 3
Dyspnea 3 3
Chest Pain 3 3
Aortic Valve Stenosis 3 3
Atrial Fibrillation 3 3
Anaphylactic Shock 3 3
Pulmonary Embolism 2 2
Edema 2 2
Extravasation 2 2
Hemoptysis 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Myocardial Infarction 2 2
Perforation 2 2
Unspecified Vascular Problem 2 2
Low Oxygen Saturation 2 2
Dyskinesia 2 2
Reaction 2 2
Tingling 2 2
Rupture 2 2
Anaphylactoid 2 2
Renal Failure 2 2
Swelling/ Edema 2 2
Sepsis 1 1
Septic Shock 1 1
Shock 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Loss of consciousness 1 1
Injury 1 1
Physical Entrapment 1 1
Ectopic Heartbeat 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Complete Heart Block 1 1
Valvular Stenosis 1 1
Pneumothorax 1 1
Paresis 1 1
Necrosis 1 1
Left Ventricular Dysfunction 1 1
Non specific EKG/ECG Changes 1 1
Fever 1 1
Foreign Body Reaction 1 1
Headache 1 1
Cardiopulmonary Arrest 1 1
Air Embolism 1 1
Anemia 1 1
Aneurysm 1 1
Atrial Flutter 1 1
Autoimmune Reaction 1 1
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Dec-19-2019
2 Edwards Lifesciences, LLC II Apr-12-2023
3 Edwards Lifesciences, LLC I Jan-31-2019
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