Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, flow directed
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
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 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 113 113
Pacing Problem 79 79
Inflation Problem 64 64
Deflation Problem 55 55
Incorrect, Inadequate or Imprecise Result or Readings 52 52
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 25 25
Detachment of Device or Device Component 23 23
Material Split, Cut or Torn 22 22
Material Separation 21 21
Break 20 20
Physical Resistance/Sticking 17 17
Fluid/Blood Leak 15 15
Difficult to Remove 15 15
No Pacing 13 13
Failure to Deflate 12 12
Material Puncture/Hole 12 12
Material Deformation 10 10
No Device Output 9 9
Difficult to Insert 8 8
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
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
Insufficient Flow or Under Infusion 4 4
Defective Component 4 4
Use of Device Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Gas/Air Leak 4 4
Inaccurate Information 4 4
Output Problem 3 3
Insufficient Information 3 3
Patient-Device Incompatibility 3 3
Device Displays Incorrect Message 3 3
High Test Results 3 3
Product Quality Problem 3 3
Contamination 3 3
Crack 3 3
Difficult to Flush 2 2
Disconnection 2 2
Pacing Inadequately 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
Unclear Information 1 1
Unintended Deflation 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Activation Failure 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 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
Improper or Incorrect Procedure or Method 1 1
Failure to Sense 1 1
Device Contamination with Body Fluid 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
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
Degraded 1 1
Material Frayed 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 442 442
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
Cardiac Tamponade 6 6
Great Vessel Perforation 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
Cardiac Arrest 4 4
Bradycardia 3 3
Chest Pain 3 3
Dyspnea 3 3
Anaphylactic Shock 3 3
High Blood Pressure/ Hypertension 3 3
Pain 3 3
Foreign Body In Patient 3 3
Unspecified Vascular Problem 2 2
Swelling/ Edema 2 2
Low Oxygen Saturation 2 2
Complaint, Ill-Defined 2 2
Hemoptysis 2 2
Perforation of Vessels 2 2
Rupture 2 2
Anaphylactoid 2 2
Perforation 2 2
Extravasation 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Atrial Fibrillation 2 2
Death 2 2
Aortic Valve Stenosis 2 2
Cardiopulmonary Arrest 1 1
Edema 1 1
Atrial Flutter 1 1
Exposure to Body Fluids 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Myocardial Infarction 1 1
Fever 1 1
Pneumothorax 1 1
Sepsis 1 1
Septic Shock 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Physical Entrapment 1 1
Tingling 1 1
Injury 1 1
Reaction 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Complete Heart Block 1 1
Ectopic Heartbeat 1 1
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
-
-