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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device occluder, catheter tip
Product CodeDQT
Regulation Number 870.1370
Device Class 2

MDR Year MDR Reports MDR Events
2019 21 21
2020 11 11
2021 2 2
2022 5 5
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 10 10
Detachment of Device or Device Component 8 8
Material Integrity Problem 6 6
Activation, Positioning or Separation Problem 6 6
Protective Measures Problem 3 3
Material Fragmentation 3 3
Mechanical Problem 2 2
Failure to Deflate 2 2
Break 2 2
Burst Container or Vessel 1 1
Fluid/Blood Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Retraction Problem 1 1
Material Separation 1 1
Unraveled Material 1 1
Material Perforation 1 1
Material Frayed 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
Device Embedded In Tissue or Plaque 12 12
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 5 5
Laceration(s) 3 3
Perforation 2 2
Exposure to Body Fluids 2 2
Death 2 2
No Patient Involvement 2 2
Foreign Body In Patient 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Insufficient Information 1 1
Electro-Mechanical Dissociation 1 1
Cardiac Tamponade 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1

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