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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
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
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 2
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILLAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW PART OF ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 2
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 85 85
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 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 308 308
Detachment of Device or Device Component 203 203
Fracture 101 101
Break 98 98
Detachment Of Device Component 90 90
Communication or Transmission Problem 88 88
Adverse Event Without Identified Device or Use Problem 77 77
Material Separation 71 71
Device Contamination with Chemical or Other Material 68 68
Incorrect Measurement 65 65
Contamination 55 55
Leak/Splash 55 55
Material Fragmentation 49 49
Failure to Advance 46 46
Difficult to Remove 44 44
Fluid/Blood Leak 33 33
Failure to Zero 25 25
Particulates 25 25
Improper or Incorrect Procedure or Method 23 23
Contamination /Decontamination Problem 22 22
Material Deformation 22 22
Use of Device Problem 21 21
Entrapment of Device 20 20
Device Operates Differently Than Expected 20 20
Difficult to Advance 19 19
Disconnection 19 19
Deformation Due to Compressive Stress 15 15
Material Integrity Problem 15 15
Appropriate Term/Code Not Available 15 15
Physical Resistance/Sticking 13 13
Material Split, Cut or Torn 12 12
Device Handling Problem 11 11
Pressure Problem 11 11
Peeled/Delaminated 11 11
Loose or Intermittent Connection 11 11
Inaccurate Flow Rate 10 10
Kinked 10 10
Unsealed Device Packaging 10 10
Stretched 9 9
Output Problem 9 9
Mechanical Jam 8 8
Device Contaminated During Manufacture or Shipping 8 8
Device Displays Incorrect Message 8 8
Connection Problem 8 8
Positioning Problem 7 7
Material Twisted/Bent 7 7
Sticking 7 7
Crack 7 7
Display or Visual Feedback Problem 6 6
Mechanical Problem 6 6
Defective Component 6 6
Insufficient Information 6 6
Defective Device 6 6
Calibration Problem 6 6
High Readings 6 6
Incorrect Or Inadequate Test Results 5 5
Air/Gas in Device 5 5
Infusion or Flow Problem 5 5
Excess Flow or Over-Infusion 5 5
No Device Output 4 4
Device Damaged Prior to Use 4 4
Difficult to Flush 4 4
Device Alarm System 4 4
Failure to Clean Adequately 4 4
Tear, Rip or Hole in Device Packaging 4 4
Obstruction of Flow 3 3
High Test Results 3 3
Physical Resistance 3 3
Contamination of Device Ingredient or Reagent 3 3
Inaccurate Information 3 3
Improper Flow or Infusion 3 3
Bent 3 3
Complete Blockage 3 3
Flushing Problem 3 3
Material Frayed 3 3
Pacing Problem 3 3
Difficult to Insert 3 3
Difficult To Position 3 3
Device Difficult to Setup or Prepare 2 2
Decrease in Pressure 2 2
Increase in Pressure 2 2
Off-Label Use 2 2
Unable to Obtain Readings 2 2
Device Inoperable 2 2
No Display/Image 2 2
Migration or Expulsion of Device 2 2
Material Discolored 2 2
Thermal Decomposition of Device 2 2
Device Sensing Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Delamination 2 2
Gas/Air Leak 2 2
Device Dislodged or Dislocated 2 2
Low Test Results 2 2
Low Readings 2 2
Expiration Date Error 2 2
Failure to Disconnect 2 2
Failure to Calibrate 1 1
Device Or Device Fragments Location Unknown 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 551 551
No Clinical Signs, Symptoms or Conditions 436 436
No Known Impact Or Consequence To Patient 366 366
Device Embedded In Tissue or Plaque 71 71
Vascular Dissection 39 39
No Patient Involvement 36 36
No Code Available 23 23
No Information 22 22
Insufficient Information 21 21
Hemorrhage/Bleeding 19 19
Blood Loss 18 18
Air Embolism 17 17
Cerebrospinal Fluid Leakage 13 13
Foreign Body In Patient 13 13
Death 10 10
Low Blood Pressure/ Hypotension 10 10
Intimal Dissection 9 9
Burn(s) 8 8
Loss of consciousness 8 8
Pericardial Effusion 6 6
Thrombosis 6 6
Unspecified Infection 4 4
High Blood Pressure/ Hypertension 4 4
Injury 3 3
Vasoconstriction 3 3
Chest Pain 3 3
Vessel Or Plaque, Device Embedded In 3 3
Arrhythmia 3 3
Exposure to Body Fluids 3 3
Bradycardia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Thrombosis/Thrombus 2 2
Cardiac Arrest 2 2
Embolism 2 2
Hematoma 2 2
Ischemia 2 2
Muscle Spasm(s) 2 2
Thrombus 2 2
Tissue Damage 2 2
Pain 2 2
Ventricular Fibrillation 2 2
Cardiac Tamponade 2 2
Obstruction/Occlusion 2 2
Perforation 2 2
ST Segment Elevation 2 2
Not Applicable 2 2
Full thickness (Third Degree) Burn 2 2
Ischemia Stroke 1 1
Tics/Tremor 1 1
Embolism/Embolus 1 1
Hypervolemia 1 1
Superficial (First Degree) Burn 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
Cardiogenic Shock 1 1
Stenosis 1 1
Perforation of Vessels 1 1
Dizziness 1 1
Electrolyte Imbalance 1 1
Paralysis 1 1
Hepatitis 1 1
Transient Ischemic Attack 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Overdose 1 1
Memory Loss/Impairment 1 1
Edema 1 1
Infarction, Cerebral 1 1
Cyanosis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Angina 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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