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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
2022 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 192 192
Detachment of Device or Device Component 137 137
Fracture 72 72
Communication or Transmission Problem 60 60
Break 59 59
Device Contamination with Chemical or Other Material 59 59
Leak/Splash 45 45
Adverse Event Without Identified Device or Use Problem 41 41
Detachment Of Device Component 32 32
Material Fragmentation 31 31
Material Separation 27 27
Failure to Advance 26 26
Contamination 25 25
Failure to Zero 24 24
Contamination /Decontamination Problem 20 20
Incorrect Measurement 19 19
Material Deformation 18 18
Difficult to Remove 17 17
Disconnection 16 16
Entrapment of Device 16 16
Fluid Leak 14 14
Material Integrity Problem 14 14
Difficult to Advance 11 11
Peeled/Delaminated 11 11
Device Operates Differently Than Expected 9 9
Pressure Problem 9 9
Physical Resistance/Sticking 9 9
Output Problem 8 8
Connection Problem 8 8
Improper or Incorrect Procedure or Method 8 8
Appropriate Term/Code Not Available 7 7
Positioning Problem 6 6
Defective Device 6 6
Device Displays Incorrect Message 5 5
Kinked 5 5
Crack 5 5
Material Twisted/Bent 5 5
Mechanical Jam 5 5
Failure to Clean Adequately 4 4
Difficult to Flush 4 4
Loose or Intermittent Connection 4 4
Unsealed Device Packaging 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Calibration Problem 4 4
Use of Device Problem 3 3
High Readings 3 3
Contamination of Device Ingredient or Reagent 3 3
Obstruction of Flow 3 3
High Test Results 3 3
Sticking 3 3
Stretched 3 3
Excess Flow or Over-Infusion 3 3
Flushing Problem 3 3
Inaccurate Flow Rate 3 3
Device Contaminated During Manufacture or Shipping 3 3
Insufficient Information 3 3
Therapeutic or Diagnostic Output Failure 2 2
Inaccurate Information 2 2
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Gas Leak 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 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
Device Inoperable 2 2
Low Test Results 2 2
Device Sensing Problem 2 2
Deformation Due to Compressive Stress 2 2
Low Readings 1 1
Failure to Disconnect 1 1
Device Operational Issue 1 1
Delamination 1 1
Activation, Positioning or SeparationProblem 1 1
Failure to Calibrate 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Failure to Select Signal 1 1
Material Rupture 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
Misconnection 1 1
Moisture Damage 1 1
No Device Output 1 1
Backflow 1 1
Material Disintegration 1 1
False Positive Result 1 1
Device Alarm System 1 1
Failure to Shut Off 1 1
Difficult to Open or Remove Packaging Material 1 1
No Flow 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 165 165
Device Embedded In Tissue or Plaque 46 46
No Patient Involvement 29 29
Vascular Dissection 15 15
Blood Loss 15 15
No Code Available 14 14
Insufficient Information 10 10
No Information 7 7
Death 7 7
Hemorrhage/Bleeding 6 6
Low Blood Pressure/ Hypotension 6 6
Air Embolism 5 5
Burn(s) 4 4
Unspecified Infection 4 4
Thrombosis 3 3
Exposure to Body Fluids 3 3
Arrhythmia 3 3
Intimal Dissection 3 3
Cerebrospinal Fluid Leakage 3 3
Foreign Body In Patient 3 3
Tissue Damage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Not Applicable 2 2
Chest Pain 2 2
Bradycardia 2 2
Pain 2 2
Muscle Spasm(s) 2 2
Myocardial Infarction 1 1
Overdose 1 1
Ischemia 1 1
Perforation 1 1
ST Segment Elevation 1 1
Thrombus 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Injury 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Vascular System (Circulation), Impaired 1 1
Infarction, Cerebral 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Hepatitis 1 1
High Blood Pressure/ Hypertension 1 1
Edema 1 1
Embolism 1 1
Hematoma 1 1
Thrombosis/Thrombus 1 1
Vasoconstriction 1 1
Hypervolemia 1 1

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