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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
2018 133 133
2019 144 144
2020 104 104
2021 97 97
2022 130 130
2023 217 217

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 121 121
Pacing Problem 74 74
Inflation Problem 72 72
Incorrect Measurement 67 67
Incorrect, Inadequate or Imprecise Result or Readings 64 64
Deflation Problem 53 53
Leak/Splash 44 44
Adverse Event Without Identified Device or Use Problem 43 43
Appropriate Term/Code Not Available 37 37
Failure to Capture 31 31
Difficult to Advance 27 27
Material Separation 24 24
Break 23 23
Material Split, Cut or Torn 22 22
Burst Container or Vessel 20 20
Physical Resistance/Sticking 19 19
Detachment of Device or Device Component 19 19
Difficult to Remove 16 16
No Pacing 14 14
Material Deformation 12 12
Fluid/Blood Leak 12 12
Material Puncture/Hole 12 12
No Device Output 10 10
Component Missing 9 9
Defective Device 9 9
Unable to Obtain Readings 8 8
Difficult to Insert 7 7
Difficult or Delayed Positioning 7 7
Material Integrity Problem 7 7
Material Twisted/Bent 6 6
Output Problem 6 6
Obstruction of Flow 6 6
Defective Component 5 5
Entrapment of Device 5 5
Activation, Positioning or Separation Problem 5 5
Failure to Deflate 5 5
Connection Problem 4 4
Patient-Device Incompatibility 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Insufficient Information 4 4
Insufficient Flow or Under Infusion 4 4
Use of Device Problem 4 4
Failure to Advance 4 4
Device Displays Incorrect Message 3 3
Failure to Calibrate 3 3
High Test Results 3 3
Flaked 3 3
Detachment Of Device Component 3 3
Contamination 3 3
Crack 3 3
Difficult to Flush 3 3
Material Fragmentation 3 3
Product Quality Problem 3 3
Unintended Movement 3 3
Device Contamination with Chemical or Other Material 3 3
Inaccurate Information 3 3
Gas/Air Leak 2 2
Material Protrusion/Extrusion 2 2
Device Dislodged or Dislocated 2 2
Capturing Problem 2 2
Data Problem 2 2
Activation Failure 2 2
Separation Problem 2 2
Mechanical Problem 2 2
Pacing Inadequately 2 2
Complete Blockage 2 2
Device Alarm System 2 2
Disconnection 2 2
Malposition of Device 2 2
High Readings 2 2
Low Readings 1 1
Structural Problem 1 1
Difficult or Delayed Activation 1 1
Device Or Device Fragments Location Unknown 1 1
Low Test Results 1 1
Device Contamination with Body Fluid 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Sense 1 1
Device Damaged Prior to Use 1 1
Retraction Problem 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Degraded 1 1
Backflow 1 1
Coagulation in Device or Device Ingredient 1 1
Pacing Intermittently 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Increase in Pressure 1 1
Off-Label Use 1 1
Migration or Expulsion of Device 1 1
Excess Flow or Over-Infusion 1 1
Air Leak 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 356 356
No Consequences Or Impact To Patient 226 226
No Known Impact Or Consequence To Patient 154 154
Insufficient Information 51 51
No Patient Involvement 18 18
Vascular Dissection 14 14
No Code Available 12 12
Arrhythmia 11 11
Hemorrhage/Bleeding 11 11
Foreign Body In Patient 8 8
Cardiac Tamponade 7 7
Death 7 7
Low Blood Pressure/ Hypotension 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Information 6 6
Device Embedded In Tissue or Plaque 5 5
Great Vessel Perforation 5 5
Pain 4 4
Needle Stick/Puncture 4 4
Pericardial Effusion 3 3
Complaint, Ill-Defined 3 3
Cardiac Perforation 3 3
Dyspnea 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 3 3
Atrial Fibrillation 3 3
Bradycardia 3 3
Cardiac Arrest 3 3
Aortic Valve Stenosis 3 3
Chest Pain 3 3
Extravasation 2 2
Pulmonary Embolism 2 2
Anaphylactic Shock 2 2
Unspecified Infection 2 2
Perforation 2 2
Dyskinesia 2 2
Reaction 2 2
Tingling 2 2
Rupture 2 2
Anaphylactoid 2 2
Unspecified Vascular Problem 2 2
Hemoptysis 2 2
Low Oxygen Saturation 2 2
Swelling/ Edema 2 2
Valvular Stenosis 1 1
Ectopic Heartbeat 1 1
Paresis 1 1
Failure of Implant 1 1
Injury 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Complete Heart Block 1 1
Pneumothorax 1 1
Sepsis 1 1
Septic Shock 1 1
Shock 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Left Ventricular Dysfunction 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Edema 1 1
Anemia 1 1
Aneurysm 1 1
Air Embolism 1 1
Atrial Flutter 1 1
Autoimmune Reaction 1 1
Exposure to Body Fluids 1 1
Fever 1 1
Foreign Body Reaction 1 1
Headache 1 1
Cardiopulmonary Arrest 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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