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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 182 182
Detachment of Device or Device Component 125 125
Fracture 67 67
Device Contamination with Chemical or Other Material 58 58
Communication or Transmission Problem 54 54
Break 48 48
Leak/Splash 45 45
Adverse Event Without Identified Device or Use Problem 37 37
Detachment Of Device Component 32 32
Material Fragmentation 31 31
Failure to Zero 22 22
Contamination 20 20
Contamination /Decontamination Problem 20 20
Material Deformation 17 17
Failure to Advance 17 17
Material Separation 16 16
Disconnection 16 16
Entrapment of Device 15 15
Incorrect Measurement 15 15
Fluid Leak 14 14
Material Integrity Problem 14 14
Pressure Problem 9 9
Physical Resistance/Sticking 9 9
Device Operates Differently Than Expected 9 9
Connection Problem 8 8
Output Problem 8 8
Peeled/Delaminated 7 7
Defective Device 6 6
Difficult to Remove 6 6
Positioning Problem 6 6
Material Twisted/Bent 5 5
Mechanical Jam 5 5
Appropriate Term/Code Not Available 5 5
Kinked 5 5
Improper or Incorrect Procedure or Method 5 5
Device Displays Incorrect Message 5 5
Crack 5 5
Difficult to Flush 4 4
Loose or Intermittent Connection 4 4
Unsealed Device Packaging 4 4
Calibration Problem 4 4
Difficult to Advance 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Failure to Clean Adequately 4 4
Obstruction of Flow 3 3
High Test Results 3 3
Sticking 3 3
Contamination of Device Ingredient or Reagent 3 3
High Readings 3 3
Excess Flow or Over-Infusion 3 3
Flushing Problem 3 3
Inaccurate Flow Rate 2 2
No Display/Image 2 2
Display or Visual Feedback Problem 2 2
Complete Blockage 2 2
Bent 2 2
Particulates 2 2
Difficult To Position 2 2
Unable to Obtain Readings 2 2
Low Test Results 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Material Split, Cut or Torn 2 2
Insufficient Information 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Gas Leak 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Failure to Shut Off 1 1
Material Protrusion/Extrusion 1 1
No Flow 1 1
Output below Specifications 1 1
Scratched Material 1 1
Unintended Movement 1 1
Device Difficult to Maintain 1 1
Data Problem 1 1
Device Handling Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Air/Gas in Device 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Stretched 1 1
Failure to Select Signal 1 1
Material Rupture 1 1
Low Readings 1 1
Failure to Disconnect 1 1
Delamination 1 1
Activation, Positioning or SeparationProblem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Reflux within Device 1 1
Decrease in Pressure 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 452 452
No Known Impact Or Consequence To Patient 212 212
No Clinical Signs, Symptoms or Conditions 99 99
Device Embedded In Tissue or Plaque 44 44
No Patient Involvement 29 29
Blood Loss 15 15
No Code Available 14 14
Vascular Dissection 12 12
Insufficient Information 7 7
No Information 7 7
Death 7 7
Air Embolism 5 5
Hemorrhage/Bleeding 4 4
Unspecified Infection 4 4
Cerebrospinal Fluid Leakage 3 3
Arrhythmia 3 3
Intimal Dissection 3 3
Exposure to Body Fluids 3 3
Burn(s) 3 3
Thrombosis 3 3
Low Blood Pressure/ Hypotension 3 3
Not Applicable 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Tissue Damage 2 2
Muscle Spasm(s) 2 2
Pain 2 2
Chest Pain 2 2
Edema 1 1
Embolism 1 1
Ischemia 1 1
Hepatitis 1 1
High Blood Pressure/ Hypertension 1 1
Infarction, Cerebral 1 1
Bradycardia 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Perforation 1 1
ST Segment Elevation 1 1
Myocardial Infarction 1 1
Overdose 1 1
Vasoconstriction 1 1
Thrombus 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Injury 1 1
Loss of consciousness 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Vascular System (Circulation), Impaired 1 1
Hypervolemia 1 1
Foreign Body In Patient 1 1

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