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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
Regulation Description Catheter tip occluder.
Product CodeDQT
Regulation Number 870.1370
Device Class 2

MDR Year MDR Reports MDR Events
2015 6 6
2016 2 2
2017 4 4
2018 12 12
2019 21 21
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or SeparationProblem 15 15
Break 10 10
Material Fragmentation 8 8
Mechanical Problem 8 8
Detachment of Device or Device Component 6 6
Fracture 6 6
Material Integrity Problem 5 5
Device Or Device Fragments Location Unknown 3 3
Material Separation 1 1
Material Perforation 1 1
Burst Container or Vessel 1 1
Crack 1 1
Fluid Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1
Knotted 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 33 33
Device Embedded In Tissue or Plaque 11 11
No Consequences Or Impact To Patient 5 5
Death 2 2
Perforation 2 2
No Patient Involvement 2 2
No Code Available 1 1
Pericardial Effusion 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Electro-Mechanical Dissociation 1 1
Cardiac Tamponade 1 1
Vascular Dissection 1 1

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