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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, catheter control, steerable
Product CodeDXX
Regulation Number 870.1290
Device Class 2


Premarket Reviews
ManufacturerDecision
CORINDUS, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2017 3 3
2018 9 9
2019 9 9
2020 4 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 3 3
Component or Accessory Incompatibility 3 3
Fail-Safe Problem 3 3
Electrical /Electronic Property Problem 2 2
Break 2 2
Display or Visual Feedback Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Electrical Shorting 2 2
Material Deformation 1 1
Power Problem 1 1
Product Quality Problem 1 1
Device-Device Incompatibility 1 1
Fail-Safe Did Not Operate 1 1
Device Operational Issue 1 1
Patient Device Interaction Problem 1 1
Device Issue 1 1
Mechanical Problem 1 1
Insufficient Information 1 1
Activation Problem 1 1
Device Displays Incorrect Message 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 10 10
No Clinical Signs, Symptoms or Conditions 2 2
Vascular Dissection 1 1
Paresthesia 1 1
Insufficient Information 1 1
Chest Pain 1 1
No Patient Involvement 1 1
Vertigo 1 1
Speech Disorder 1 1
Electric Shock 1 1
Movement Disorder 1 1

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