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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transducer, pressure, catheter tip
Product CodeDXO
Regulation Number 870.2870
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFECIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MILLAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL (NOW PART OF ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 114 114
2016 152 152
2017 186 186
2018 179 179
2019 153 153
2020 158 158
2021 116 116
2022 144 144
2023 194 194
2024 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 299 299
Detachment of Device or Device Component 194 194
Fracture 101 101
Break 97 97
Communication or Transmission Problem 87 87
Detachment Of Device Component 78 78
Adverse Event Without Identified Device or Use Problem 75 75
Material Separation 70 70
Device Contamination with Chemical or Other Material 65 65
Incorrect Measurement 59 59
Leak/Splash 52 52
Contamination 52 52
Material Fragmentation 49 49
Failure to Advance 45 45
Difficult to Remove 42 42
Fluid/Blood Leak 31 31
Failure to Zero 25 25
Improper or Incorrect Procedure or Method 23 23
Particulates 22 22
Contamination /Decontamination Problem 22 22
Material Deformation 21 21
Use of Device Problem 21 21
Entrapment of Device 20 20
Difficult to Advance 19 19
Disconnection 18 18
Device Operates Differently Than Expected 17 17
Deformation Due to Compressive Stress 15 15
Material Integrity Problem 15 15
Physical Resistance/Sticking 13 13
Material Split, Cut or Torn 12 12
Pressure Problem 11 11
Peeled/Delaminated 11 11
Kinked 10 10
Unsealed Device Packaging 10 10
Loose or Intermittent Connection 9 9
Output Problem 9 9
Appropriate Term/Code Not Available 9 9
Connection Problem 8 8
Inaccurate Flow Rate 8 8
Stretched 8 8
Crack 7 7
Material Twisted/Bent 7 7
Mechanical Jam 7 7
Device Contaminated During Manufacture or Shipping 7 7
Positioning Problem 7 7
Calibration Problem 6 6
Defective Device 6 6
Device Displays Incorrect Message 6 6
Mechanical Problem 6 6
Sticking 6 6
Defective Component 5 5
Incorrect Or Inadequate Test Results 5 5
Excess Flow or Over-Infusion 5 5
Insufficient Information 5 5
Air/Gas in Device 5 5
Failure to Clean Adequately 4 4
Device Damaged Prior to Use 4 4
Infusion or Flow Problem 4 4
Display or Visual Feedback Problem 4 4
Difficult to Flush 4 4
Device Alarm System 4 4
No Device Output 4 4
Difficult To Position 3 3
High Test Results 3 3
High Readings 3 3
Tear, Rip or Hole in Device Packaging 3 3
Obstruction of Flow 3 3
Bent 3 3
Complete Blockage 3 3
Flushing Problem 3 3
Material Frayed 3 3
Improper Flow or Infusion 3 3
Physical Resistance 3 3
Contamination of Device Ingredient or Reagent 3 3
Inaccurate Information 3 3
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Delamination 2 2
Expiration Date Error 2 2
Failure to Disconnect 2 2
Gas/Air Leak 2 2
Device Sensing Problem 2 2
Device Dislodged or Dislocated 2 2
Difficult to Insert 2 2
Migration or Expulsion of Device 2 2
No Display/Image 2 2
Material Discolored 2 2
Low Readings 2 2
Low Test Results 2 2
Device Inoperable 2 2
Device Difficult to Setup or Prepare 2 2
Pacing Problem 2 2
Increase in Pressure 2 2
Off-Label Use 2 2
Unable to Obtain Readings 2 2
Reflux within Device 1 1
Failure to Reset 1 1
Material Rupture 1 1
Decrease in Pressure 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 534 534
No Clinical Signs, Symptoms or Conditions 428 428
No Known Impact Or Consequence To Patient 312 312
Device Embedded In Tissue or Plaque 71 71
Vascular Dissection 37 37
No Patient Involvement 35 35
No Code Available 22 22
Insufficient Information 21 21
No Information 19 19
Blood Loss 18 18
Hemorrhage/Bleeding 18 18
Air Embolism 16 16
Cerebrospinal Fluid Leakage 13 13
Foreign Body In Patient 13 13
Death 9 9
Intimal Dissection 9 9
Low Blood Pressure/ Hypotension 9 9
Loss of consciousness 8 8
Burn(s) 7 7
Thrombosis 6 6
Pericardial Effusion 6 6
High Blood Pressure/ Hypertension 4 4
Unspecified Infection 4 4
Chest Pain 3 3
Vessel Or Plaque, Device Embedded In 3 3
Exposure to Body Fluids 3 3
Bradycardia 3 3
Arrhythmia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Injury 3 3
Vasoconstriction 3 3
Ventricular Fibrillation 2 2
Cardiac Tamponade 2 2
Tissue Damage 2 2
Obstruction/Occlusion 2 2
Not Applicable 2 2
Cardiac Arrest 2 2
Ischemia 2 2
Muscle Spasm(s) 2 2
Hematoma 2 2
Pain 2 2
Perforation 2 2
ST Segment Elevation 2 2
Thrombosis/Thrombus 2 2
Thrombus 1 1
Paralysis 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Overdose 1 1
Memory Loss/Impairment 1 1
Infarction, Cerebral 1 1
Cyanosis 1 1
Edema 1 1
Embolism 1 1
Hepatitis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Hypervolemia 1 1
Superficial (First Degree) Burn 1 1
Ischemia Stroke 1 1
Tics/Tremor 1 1
Embolism/Embolus 1 1
Skin Inflammation 1 1
Low Oxygen Saturation 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Vascular System (Circulation), Impaired 1 1
Transient Ischemic Attack 1 1
Cardiogenic Shock 1 1
Perforation of Vessels 1 1
Dizziness 1 1
Electrolyte Imbalance 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edward Lifesciences, Llc II Sep-16-2015
2 Edwards Lifesciences, LLC II Jun-25-2021
3 Edwards Lifesciences, LLC II Dec-17-2015
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