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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 105 105

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 165 165
Detachment of Device or Device Component 154 154
Communication or Transmission Problem 85 85
Material Separation 64 64
Incorrect Measurement 55 55
Contamination 52 52
Break 44 44
Failure to Advance 43 43
Device Contamination with Chemical or Other Material 38 38
Difficult to Remove 36 36
Adverse Event Without Identified Device or Use Problem 34 34
Fracture 29 29
Fluid/Blood Leak 25 25
Failure to Zero 24 24
Leak/Splash 22 22
Improper or Incorrect Procedure or Method 19 19
Contamination /Decontamination Problem 19 19
Material Deformation 19 19
Difficult to Advance 17 17
Deformation Due to Compressive Stress 16 16
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
Stretched 6 6
Defective Device 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 6 6
Unsealed Device Packaging 6 6
Peeled/Delaminated 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
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Flushing Problem 3 3
Pacing 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
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
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
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Material Perforation 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
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 447 447
No Consequences Or Impact To Patient 223 223
No Known Impact Or Consequence To Patient 129 129
Insufficient Information 21 21
Hemorrhage/Bleeding 19 19
No Patient Involvement 18 18
Vascular Dissection 18 18
Device Embedded In Tissue or Plaque 15 15
Foreign Body In Patient 12 12
Cerebrospinal Fluid Leakage 12 12
Air Embolism 9 9
No Code Available 9 9
Blood Loss 8 8
Low Blood Pressure/ Hypotension 7 7
Loss of consciousness 7 7
Burn(s) 6 6
Pericardial Effusion 6 6
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
Transient Ischemic Attack 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
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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