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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
2014 2 2
2015 6 6
2016 2 2
2017 4 4
2018 12 12
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
Activation, Positioning or Separation Problem 15 15
Fracture 10 10
Break 10 10
Material Fragmentation 10 10
Mechanical Problem 8 8
Detachment of Device or Device Component 8 8
Material Integrity Problem 6 6
Device Or Device Fragments Location Unknown 4 4
Protective Measures Problem 3 3
Failure to Deflate 2 2
Leak/Splash 1 1
Material Frayed 1 1
Burst Container or Vessel 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Knotted 1 1
Unraveled Material 1 1
Material Perforation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Retraction Problem 1 1
Material Separation 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34 34
Device Embedded In Tissue or Plaque 14 14
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 5 5
Laceration(s) 3 3
Death 2 2
Perforation 2 2
Exposure to Body Fluids 2 2
No Patient Involvement 2 2
Air Embolism 1 1
No Code Available 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Cardiac Arrest 1 1
Electro-Mechanical Dissociation 1 1
Cardiac Tamponade 1 1
Ventricular Fibrillation 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Perforation of Vessels 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular I Nov-15-2013
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