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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
2019 15 15
2020 13 13
2021 20 20
2022 27 27
2023 22 22
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 38 38
Display or Visual Feedback Problem 19 19
Material Rupture 15 15
Leak/Splash 15 15
Adverse Event Without Identified Device or Use Problem 10 10
Material Puncture/Hole 4 4
Failure to Unfold or Unwrap 4 4
Component Missing 4 4
Improper Flow or Infusion 4 4
Fracture 2 2
No Visual Prompts/Feedback 2 2
Appropriate Term/Code Not Available 1 1
Misassembled 1 1
Device Difficult to Setup or Prepare 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
No Consequences Or Impact To Patient 23 23
Vascular Dissection 3 3
Stroke/CVA 3 3
Hemorrhage/Bleeding 3 3
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Transient Ischemic Attack 2 2
Vasoconstriction 2 2
Perforation of Vessels 1 1
Embolism/Embolus 1 1
Insufficient Information 1 1
Rupture 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
No Patient Involvement 1 1
Intracranial Hemorrhage 1 1
Inflammation 1 1
Paralysis 1 1
Perforation 1 1
Feeding Problem 1 1
Fistula 1 1
Hematoma 1 1

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