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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aspiration thrombectomy catheter
Definition To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Product CodeQEZ
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
KANEKA MEDICAL AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 1
WALK VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 2 2
2022 18 18
2023 14 14
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Detachment of Device or Device Component 3 3
No Apparent Adverse Event 2 2
Difficult to Insert 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 1 1
Electro-Static Discharge 1 1
Suction Problem 1 1
Expiration Date Error 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Loose or Intermittent Connection 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Difficult to Advance 1 1
Material Twisted/Bent 1 1
Break 1 1
Entrapment of Device 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Hemorrhage/Bleeding 4 4
Cardiac Arrest 3 3
Pulmonary Embolism 2 2
Cardiac Tamponade 2 2
Decreased Respiratory Rate 2 2
Non specific EKG/ECG Changes 2 2
Foreign Body In Patient 2 2
Hematoma 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2
Insufficient Information 2 2
Tics/Tremor 1 1
Fever 1 1
Cardiac Perforation 1 1
Diminished Pulse Pressure 1 1
Anemia 1 1
Stroke/CVA 1 1
Low Blood Pressure/ Hypotension 1 1
Infiltration into Tissue 1 1
Perforation of Vessels 1 1

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