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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
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 112 112
Pacing Problem 67 67
Inflation Problem 61 61
Deflation Problem 52 52
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Incorrect Measurement 45 45
Leak/Splash 42 42
Adverse Event Without Identified Device or Use Problem 39 39
Appropriate Term/Code Not Available 30 30
Difficult to Advance 27 27
Failure to Capture 27 27
Burst Container or Vessel 21 21
Material Separation 21 21
Material Split, Cut or Torn 21 21
Detachment of Device or Device Component 20 20
Break 20 20
Physical Resistance/Sticking 17 17
Difficult to Remove 15 15
No Pacing 13 13
Fluid/Blood Leak 12 12
Material Puncture/Hole 12 12
Material Deformation 10 10
Failure to Deflate 9 9
No Device Output 9 9
Unable to Obtain Readings 8 8
Defective Device 8 8
Material Integrity Problem 8 8
Component Missing 7 7
Difficult or Delayed Positioning 7 7
Difficult to Insert 6 6
Obstruction of Flow 6 6
Material Twisted/Bent 6 6
Therapeutic or Diagnostic Output Failure 4 4
Inaccurate Information 4 4
Failure to Advance 4 4
Connection Problem 4 4
Activation, Positioning or Separation Problem 4 4
Use of Device Problem 4 4
Insufficient Flow or Under Infusion 4 4
Defective Component 4 4
Entrapment of Device 4 4
Material Fragmentation 4 4
Contamination 3 3
Crack 3 3
Product Quality Problem 3 3
Patient-Device Incompatibility 3 3
Device Displays Incorrect Message 3 3
High Test Results 3 3
Gas/Air Leak 3 3
Output Problem 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Separation Problem 2 2
Insufficient Information 2 2
Malposition of Device 2 2
Capturing Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Pacing Inadequately 2 2
Difficult to Flush 2 2
Disconnection 2 2
Degraded 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Pacing Intermittently 1 1
Particulates 1 1
Increase in Pressure 1 1
Off-Label Use 1 1
Excess Flow or Over-Infusion 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Device Contamination with Body Fluid 1 1
Improper or Incorrect Procedure or Method 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Retraction Problem 1 1
Failure to Sense 1 1
Contamination /Decontamination Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Difficult or Delayed Activation 1 1
Low Test Results 1 1
Structural Problem 1 1
Failure to Calibrate 1 1
Unclear Information 1 1
Unintended Deflation 1 1
Activation Failure 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 1 1
Pressure Problem 1 1
Temperature 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 146 146
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 54 54
Hemorrhage/Bleeding 12 12
Vascular Dissection 11 11
No Patient Involvement 10 10
Arrhythmia 9 9
No Code Available 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Information 6 6
Great Vessel Perforation 6 6
Cardiac Tamponade 6 6
Low Blood Pressure/ Hypotension 6 6
Cardiac Perforation 5 5
Needle Stick/Puncture 4 4
Device Embedded In Tissue or Plaque 4 4
Hypersensitivity/Allergic reaction 4 4
High Blood Pressure/ Hypertension 3 3
Pain 3 3
Anaphylactic Shock 3 3
Bradycardia 3 3
Cardiac Arrest 3 3
Chest Pain 3 3
Dyspnea 3 3
Foreign Body In Patient 3 3
Low Oxygen Saturation 2 2
Complaint, Ill-Defined 2 2
Rupture 2 2
Anaphylactoid 2 2
Perforation of Vessels 2 2
Unspecified Vascular Problem 2 2
Swelling/ Edema 2 2
Extravasation 2 2
Death 2 2
Atrial Fibrillation 2 2
Perforation 2 2
Aortic Valve Stenosis 2 2
Hemoptysis 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Myocardial Infarction 1 1
Pneumothorax 1 1
Sepsis 1 1
Septic Shock 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Atrial Flutter 1 1
Exposure to Body Fluids 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Cardiopulmonary Arrest 1 1
Fever 1 1
Edema 1 1
Ectopic Heartbeat 1 1
Tingling 1 1
Injury 1 1
Reaction 1 1
Physical Entrapment 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Complete Heart Block 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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