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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
OPSENS INC
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 161 161
Detachment of Device or Device Component 148 148
Communication or Transmission Problem 83 83
Material Separation 60 60
Incorrect Measurement 51 51
Contamination 51 51
Break 42 42
Failure to Advance 40 40
Device Contamination with Chemical or Other Material 38 38
Adverse Event Without Identified Device or Use Problem 34 34
Difficult to Remove 33 33
Fracture 29 29
Fluid/Blood Leak 24 24
Failure to Zero 24 24
Leak/Splash 22 22
Improper or Incorrect Procedure or Method 19 19
Contamination /Decontamination Problem 19 19
Material Deformation 18 18
Difficult to Advance 17 17
Deformation Due to Compressive Stress 15 15
Use of Device Problem 14 14
Material Integrity Problem 14 14
Disconnection 12 12
Entrapment of Device 10 10
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 10 10
Output Problem 8 8
Inaccurate Flow Rate 7 7
Device Contaminated During Manufacture or Shipping 7 7
Defective Device 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 6 6
Unsealed Device Packaging 6 6
Peeled/Delaminated 5 5
Stretched 5 5
Calibration Problem 5 5
Air/Gas in Device 5 5
Failure to Clean Adequately 4 4
Positioning Problem 4 4
Material Twisted/Bent 4 4
Mechanical Jam 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Inaccurate Information 3 3
Contamination of Device Ingredient or Reagent 3 3
Defective Component 3 3
Flushing Problem 3 3
Material Frayed 3 3
Crack 3 3
Material Discolored 2 2
No Display/Image 2 2
Display or Visual Feedback Problem 2 2
Pacing Problem 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 2 2
Unable to Obtain Readings 2 2
Device Damaged Prior to Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Sensing Problem 2 2
Connection Problem 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 1 1
Output below Specifications 1 1
Data Problem 1 1
Incomplete or Inadequate Connection 1 1
No Flow 1 1
Pressure Problem 1 1
Scratched Material 1 1
Difficult to Open or Remove Packaging Material 1 1
Electromagnetic Compatibility Problem 1 1
Gas/Air Leak 1 1
Activation, Positioning or Separation Problem 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
High Test Results 1 1
Low Test Results 1 1
Low Readings 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Material Perforation 1 1
Failure to Reset 1 1
Material Rupture 1 1
Moisture Damage 1 1
No Device Output 1 1
False Positive Result 1 1
Thermal Decomposition of Device 1 1
Complete Blockage 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Device Alarm System 1 1
Difficult to Flush 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
No Consequences Or Impact To Patient 223 223
No Known Impact Or Consequence To Patient 129 129
Insufficient Information 21 21
No Patient Involvement 18 18
Vascular Dissection 18 18
Hemorrhage/Bleeding 18 18
Device Embedded In Tissue or Plaque 15 15
Foreign Body In Patient 11 11
Cerebrospinal Fluid Leakage 11 11
Air Embolism 9 9
No Code Available 9 9
Blood Loss 8 8
Loss of consciousness 7 7
Burn(s) 6 6
Low Blood Pressure/ Hypotension 6 6
Pericardial Effusion 5 5
Unspecified Infection 4 4
High Blood Pressure/ Hypertension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Thrombosis/Thrombus 2 2
Bradycardia 2 2
Obstruction/Occlusion 2 2
Perforation 2 2
Vasoconstriction 2 2
Death 2 2
Cardiac Arrest 2 2
Chest Pain 1 1
Cyanosis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Hematoma 1 1
Hepatitis 1 1
Ischemia 1 1
Memory Loss/Impairment 1 1
Muscle Weakness 1 1
Overdose 1 1
Paralysis 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Dizziness 1 1
Electrolyte Imbalance 1 1
ST Segment Elevation 1 1
Thrombosis 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Low Oxygen Saturation 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Cardiac Tamponade 1 1
Superficial (First Degree) Burn 1 1
Ischemia Stroke 1 1
Tics/Tremor 1 1
Embolism/Embolus 1 1

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