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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
Regulation Description Catheter tip pressure transducer.
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 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL (NOW PART OF ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 152 152
2017 186 186
2018 179 179
2019 153 153
2020 158 158
2021 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 210 210
Detachment of Device or Device Component 125 125
Fracture 86 86
Break 62 62
Device Contamination with Chemical or Other Material 62 62
Detachment Of Device Component 60 60
Communication or Transmission Problem 55 55
Leak/Splash 47 47
Material Fragmentation 45 45
Adverse Event Without Identified Device or Use Problem 42 42
Failure to Zero 22 22
Contamination /Decontamination Problem 20 20
Material Deformation 18 18
Failure to Advance 18 18
Contamination 18 18
Disconnection 17 17
Entrapment of Device 16 16
Material Separation 16 16
Device Operates Differently Than Expected 14 14
Fluid Leak 14 14
Incorrect Measurement 14 14
Material Integrity Problem 13 13
Pressure Problem 11 11
Physical Resistance/Sticking 9 9
Difficult to Remove 9 9
Output Problem 8 8
Particulates 8 8
Connection Problem 8 8
Kinked 8 8
Peeled/Delaminated 7 7
Positioning Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Device Displays Incorrect Message 6 6
Unsealed Device Packaging 6 6
Defective Device 6 6
Calibration Problem 5 5
Excess Flow or Over-Infusion 5 5
Appropriate Term/Code Not Available 5 5
Mechanical Jam 5 5
Sticking 5 5
Loose or Intermittent Connection 5 5
Difficult to Advance 5 5
Failure to Clean Adequately 4 4
Defective Component 4 4
Material Twisted/Bent 4 4
Difficult to Flush 4 4
Crack 4 4
Flushing Problem 3 3
Obstruction of Flow 3 3
Bent 3 3
Use of Device Problem 3 3
Device Damaged Prior to Use 3 3
High Test Results 3 3
High Readings 3 3
Contamination of Device Ingredient or Reagent 3 3
Low Readings 2 2
Low Test Results 2 2
Device Inoperable 2 2
Unable to Obtain Readings 2 2
Inaccurate Flow Rate 2 2
Device Alarm System 2 2
Stretched 2 2
Difficult To Position 2 2
Incorrect Or Inadequate Test Results 2 2
Migration or Expulsion of Device 2 2
Complete Blockage 2 2
No Display/Image 2 2
Display or Visual Feedback Problem 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Device Dislodged or Dislocated 2 2
Gas Leak 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Material Protrusion/Extrusion 1 1
Failure to Shut Off 1 1
Delamination 1 1
Activation, Positioning or SeparationProblem 1 1
No Flow 1 1
False Positive Result 1 1
False Reading From Device Non-Compliance 1 1
Fire 1 1
Material Disintegration 1 1
No Device Output 1 1
Mechanical Problem 1 1
Device Operational Issue 1 1
Difficult to Open or Remove Packaging Material 1 1
Microbial Contamination of Device 1 1
Backflow 1 1
Component Falling 1 1
Difficult to Insert 1 1
Reflux within Device 1 1
Material Rupture 1 1
Failure to Read Input Signal 1 1
Failure to Select Signal 1 1
Misconnection 1 1
Moisture Damage 1 1
Output above Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 512 512
No Known Impact Or Consequence To Patient 260 260
No Clinical Signs, Symptoms or Conditions 81 81
Device Embedded In Tissue or Plaque 61 61
No Patient Involvement 35 35
Vascular Dissection 21 21
Blood Loss 15 15
No Code Available 15 15
No Information 11 11
Death 8 8
Thrombosis 6 6
Insufficient Information 6 6
Air Embolism 5 5
Low Blood Pressure/ Hypotension 4 4
Intimal Dissection 4 4
Unspecified Infection 4 4
Arrhythmia 3 3
Exposure to Body Fluids 3 3
Chest Pain 3 3
Foreign Body In Patient 3 3
Burn(s) 3 3
Cerebrospinal Fluid Leakage 3 3
Muscle Spasm(s) 2 2
Vessel Or Plaque, Device Embedded In 2 2
ST Segment Elevation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vasoconstriction 2 2
Not Applicable 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Tissue Damage 2 2
Injury 2 2
Cardiac Perforation 1 1
Burn, Thermal 1 1
Vascular System (Circulation), Impaired 1 1
Cardiogenic Shock 1 1
Myocardial Infarction 1 1
Overdose 1 1
Edema 1 1
Embolism 1 1
Bradycardia 1 1
Infarction, Cerebral 1 1
Bacterial Infection 1 1
Hypervolemia 1 1
Thrombus 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Loss of consciousness 1 1
Perforation 1 1
Ischemia 1 1
Hepatitis 1 1
High Blood Pressure/ Hypertension 1 1

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