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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 1
EDWARDS LIFECIENCES, 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 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL (NOW PART OF ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 186 186
2018 179 179
2019 153 153
2020 158 158
2021 116 116
2022 144 144
2023 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 211 211
Detachment of Device or Device Component 169 169
Communication or Transmission Problem 79 79
Fracture 76 76
Break 71 71
Device Contamination with Chemical or Other Material 59 59
Adverse Event Without Identified Device or Use Problem 59 59
Material Separation 54 54
Leak/Splash 46 46
Incorrect Measurement 42 42
Failure to Advance 37 37
Contamination 35 35
Detachment Of Device Component 32 32
Material Fragmentation 31 31
Difficult to Remove 30 30
Fluid/Blood Leak 29 29
Failure to Zero 25 25
Contamination /Decontamination Problem 22 22
Material Deformation 20 20
Entrapment of Device 18 18
Disconnection 16 16
Improper or Incorrect Procedure or Method 15 15
Material Integrity Problem 15 15
Difficult to Advance 15 15
Physical Resistance/Sticking 13 13
Use of Device Problem 12 12
Peeled/Delaminated 11 11
Deformation Due to Compressive Stress 11 11
Device Operates Differently Than Expected 9 9
Output Problem 9 9
Pressure Problem 9 9
Connection Problem 8 8
Material Split, Cut or Torn 8 8
Inaccurate Flow Rate 8 8
Loose or Intermittent Connection 8 8
Appropriate Term/Code Not Available 7 7
Device Contaminated During Manufacture or Shipping 6 6
Positioning Problem 6 6
Material Twisted/Bent 6 6
Unsealed Device Packaging 6 6
Crack 6 6
Defective Device 6 6
Stretched 6 6
Kinked 5 5
Device Displays Incorrect Message 5 5
Calibration Problem 5 5
Defective Component 5 5
Mechanical Problem 5 5
Mechanical Jam 5 5
Air/Gas in Device 5 5
Failure to Clean Adequately 4 4
Insufficient Information 4 4
Difficult to Flush 4 4
Device Damaged Prior to Use 4 4
Obstruction of Flow 3 3
High Test Results 3 3
High Readings 3 3
Sticking 3 3
Flushing Problem 3 3
Excess Flow or Over-Infusion 3 3
Complete Blockage 3 3
Contamination of Device Ingredient or Reagent 3 3
Inaccurate Information 3 3
Device Sensing Problem 2 2
Device Dislodged or Dislocated 2 2
Gas/Air Leak 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Discolored 2 2
Bent 2 2
No Display/Image 2 2
Display or Visual Feedback Problem 2 2
Particulates 2 2
No Device Output 2 2
Device Inoperable 2 2
Difficult To Position 2 2
Unable to Obtain Readings 2 2
Low Test Results 2 2
Tear, Rip or Hole in Device Packaging 2 2
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Failure to Calibrate 1 1
Low Readings 1 1
Failure to Disconnect 1 1
Battery Problem 1 1
Reflux within Device 1 1
Decrease in Pressure 1 1
Material Rupture 1 1
Failure to Select Signal 1 1
Material Perforation 1 1
Pacing Problem 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Difficult to Insert 1 1
Material Disintegration 1 1
False Positive Result 1 1
Backflow 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 452 452
No Clinical Signs, Symptoms or Conditions 321 321
No Known Impact Or Consequence To Patient 212 212
Device Embedded In Tissue or Plaque 47 47
No Patient Involvement 29 29
Vascular Dissection 25 25
Insufficient Information 19 19
Blood Loss 15 15
Hemorrhage/Bleeding 15 15
No Code Available 14 14
Air Embolism 13 13
Cerebrospinal Fluid Leakage 13 13
Foreign Body In Patient 10 10
Loss of consciousness 8 8
Low Blood Pressure/ Hypotension 8 8
Death 7 7
No Information 7 7
Burn(s) 6 6
Unspecified Infection 4 4
Pericardial Effusion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
High Blood Pressure/ Hypertension 3 3
Thrombosis 3 3
Arrhythmia 3 3
Intimal Dissection 3 3
Exposure to Body Fluids 3 3
Bradycardia 3 3
Cardiac Arrest 2 2
Chest Pain 2 2
Perforation 2 2
Pain 2 2
Ischemia 2 2
Muscle Spasm(s) 2 2
Obstruction/Occlusion 2 2
Tissue Damage 2 2
Thrombosis/Thrombus 2 2
Not Applicable 2 2
Ischemia Stroke 1 1
Tics/Tremor 1 1
Embolism/Embolus 1 1
Transient Ischemic Attack 1 1
Vasoconstriction 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Dizziness 1 1
Electrolyte Imbalance 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Injury 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
Hypervolemia 1 1
Superficial (First Degree) Burn 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Overdose 1 1
Memory Loss/Impairment 1 1
Paralysis 1 1
Hepatitis 1 1
ST Segment Elevation 1 1
Thrombus 1 1
Cyanosis 1 1
Infarction, Cerebral 1 1
Edema 1 1
Embolism 1 1
Hematoma 1 1
Vessel Or Plaque, Device Embedded In 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Jun-25-2021
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