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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary mechanical thrombectomy with aspiration
Definition To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Product CodeQEX
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
CAPTURE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SE - WITH LIMITATIONS 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 30 30
2021 81 81
2022 16 16
2023 25 25
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 75 75
Break 71 71
Material Deformation 50 50
Fracture 32 32
Failure to Advance 19 19
Suction Failure 10 10
Material Puncture/Hole 9 9
Adverse Event Without Identified Device or Use Problem 3 3
Connection Problem 2 2
Leak/Splash 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Difficult to Remove 1 1
Stretched 1 1
Material Twisted/Bent 1 1
Migration 1 1
Suction Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 154 154
No Consequences Or Impact To Patient 46 46
Foreign Body In Patient 9 9
Encephalopathy 1 1
Stroke/CVA 1 1
Death 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Perforation of Vessels 1 1

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