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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, balloon type
Product CodeGBA
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 51 51
2018 34 34
2019 15 15
2020 13 13
2021 20 20
2022 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 30 30
Adverse Event Without Identified Device or Use Problem 27 27
Leak/Splash 26 26
Display or Visual Feedback Problem 20 20
Material Rupture 19 19
Incorrect Measurement 11 11
Burst Container or Vessel 5 5
Break 4 4
Failure to Unfold or Unwrap 4 4
Material Puncture/Hole 4 4
Improper Flow or Infusion 4 4
Component Missing 3 3
Hole In Material 3 3
Air Leak 2 2
No Visual Prompts/Feedback 2 2
Material Deformation 1 1
Positioning Problem 1 1
Torn Material 1 1
Appropriate Term/Code Not Available 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Material Separation 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 69 69
No Clinical Signs, Symptoms or Conditions 42 42
Vascular Dissection 13 13
No Patient Involvement 11 11
Stroke/CVA 10 10
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 3 3
Hemorrhage, Subarachnoid 2 2
Device Embedded In Tissue or Plaque 2 2
No Code Available 1 1
Insufficient Information 1 1
Neurological Deficit/Dysfunction 1 1
Thrombosis 1 1
Vasoconstriction 1 1
Perforation of Vessels 1 1
Death 1 1
Feeding Problem 1 1
Fistula 1 1
Hematoma 1 1
Hemorrhage, Cerebral 1 1
Rupture 1 1
Perforation of Esophagus 1 1
Coma 1 1
Loss of consciousness 1 1

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