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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 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 112 112
Pacing Problem 69 69
Inflation Problem 62 62
Deflation Problem 53 53
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Incorrect Measurement 46 46
Leak/Splash 42 42
Adverse Event Without Identified Device or Use Problem 39 39
Appropriate Term/Code Not Available 30 30
Difficult to Advance 28 28
Failure to Capture 27 27
Burst Container or Vessel 23 23
Material Separation 21 21
Detachment of Device or Device Component 21 21
Material Split, Cut or Torn 21 21
Break 20 20
Physical Resistance/Sticking 17 17
Difficult to Remove 15 15
Fluid/Blood Leak 13 13
No Pacing 13 13
Material Puncture/Hole 12 12
Failure to Deflate 11 11
Material Deformation 10 10
No Device Output 9 9
Unable to Obtain Readings 8 8
Difficult to Insert 8 8
Defective Device 8 8
Material Integrity Problem 8 8
Component Missing 7 7
Difficult or Delayed Positioning 7 7
Obstruction of Flow 6 6
Material Twisted/Bent 6 6
Material Fragmentation 5 5
Entrapment of Device 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
Gas/Air Leak 4 4
Therapeutic or Diagnostic Output Failure 4 4
Inaccurate Information 4 4
Insufficient Information 3 3
Output Problem 3 3
Patient-Device Incompatibility 3 3
Device Displays Incorrect Message 3 3
High Test Results 3 3
Contamination 3 3
Crack 3 3
Product Quality Problem 3 3
Pacing Inadequately 2 2
Difficult to Flush 2 2
Disconnection 2 2
Malposition of Device 2 2
Capturing Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Separation Problem 2 2
Activation Failure 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Unclear Information 1 1
Unintended Deflation 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 414 414
No Consequences Or Impact To Patient 146 146
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 55 55
Hemorrhage/Bleeding 13 13
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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