• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device occluder, catheter tip
Product CodeDQT
Regulation Number 870.1370
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 12 12
2019 21 21
2020 11 11
2021 2 2
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or SeparationProblem 13 13
Detachment of Device or Device Component 8 8
Mechanical Problem 8 8
Break 7 7
Fracture 7 7
Material Fragmentation 7 7
Material Integrity Problem 6 6
Protective Measures Problem 3 3
Physical Resistance/Sticking 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
Device Or Device Fragments Location Unknown 1 1
Knotted 1 1
Leak/Splash 1 1
Burst Container or Vessel 1 1
Crack 1 1
Fluid Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 28 28
Device Embedded In Tissue or Plaque 12 12
No Consequences Or Impact To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Laceration(s) 3 3
Perforation 2 2
Exposure to Body Fluids 2 2
Death 2 2
No Patient Involvement 2 2
Pericardial Effusion 1 1
Insufficient Information 1 1
Vascular Dissection 1 1
Electro-Mechanical Dissociation 1 1
Cardiac Tamponade 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1

-
-