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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, embolectomy
Regulation Description Embolectomy catheter.
Product CodeDXE
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICHOR VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
PENUMBRA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 795 795
2017 770 770
2018 615 615
2019 594 594
2020 547 547
2021 242 242

Device Problems MDRs with this Device Problem Events in those MDRs
Break 563 563
Aspiration Issue 477 477
Device Displays Incorrect Message 451 451
Material Deformation 417 417
Adverse Event Without Identified Device or Use Problem 296 296
Physical Resistance/Sticking 215 215
Kinked 203 203
Material Rupture 194 194
Material Separation 173 173
Device Damaged Prior to Use 168 168
Deflation Problem 148 148
Physical Resistance 120 120
Detachment of Device or Device Component 114 114
Failure to Advance 114 114
Leak/Splash 97 97
Suction Problem 95 95
Entrapment of Device 83 83
Out-Of-Box Failure 73 73
Device Handling Problem 70 70
Device Operates Differently Than Expected 67 67
Failure to Prime 63 63
Detachment Of Device Component 61 61
Fracture 56 56
Collapse 53 53
Material Fragmentation 48 48
Display or Visual Feedback Problem 47 47
Stretched 44 44
Burst Container or Vessel 37 37
Fluid Leak 36 36
Deformation Due to Compressive Stress 36 36
Difficult to Remove 35 35
Material Twisted/Bent 33 33
Difficult to Advance 30 30
Inflation Problem 28 28
Bent 28 28
Material Puncture/Hole 27 27
Hole In Material 23 23
Device Difficult to Setup or Prepare 22 22
Device Dislodged or Dislocated 22 22
Unraveled Material 22 22
Material Integrity Problem 20 20
Suction Failure 16 16
Material Perforation 16 16
Defective Device 15 15
Mechanical Problem 14 14
Crack 13 13
Mechanical Jam 13 13
Appropriate Term/Code Not Available 13 13
Difficult to Insert 13 13
Decrease in Suction 12 12
Device Fell 10 10
Torn Material 10 10
Retraction Problem 9 9
Use of Device Problem 8 8
Device Damaged by Another Device 8 8
Material Split, Cut or Torn 8 8
Pressure Problem 8 8
Contamination 7 7
Pumping Problem 7 7
Component Missing 7 7
Device Slipped 7 7
Complete Blockage 7 7
Separation Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Device Contamination with Body Fluid 6 6
No Pressure 6 6
Device Contamination with Chemical or Other Material 5 5
Defective Component 5 5
Misconnection 5 5
Material Frayed 5 5
Cut In Material 5 5
Device Packaging Compromised 5 5
Device Operational Issue 4 4
Migration or Expulsion of Device 4 4
Unsealed Device Packaging 4 4
Unintended Movement 4 4
Migration 4 4
Power Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Inoperable 3 3
Failure to Power Up 3 3
Nonstandard Device 3 3
Air Leak 3 3
Split 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Structural Problem 3 3
Device Or Device Fragments Location Unknown 3 3
Unexpected Shutdown 3 3
Insufficient Information 3 3
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Deflate 2 2
Noise, Audible 2 2
Folded 2 2
Failure to Osseointegrate 2 2
Incomplete or Missing Packaging 2 2
Failure to Deliver 2 2
Obstruction of Flow 2 2
Difficult to Open or Close 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2229 2229
No Known Impact Or Consequence To Patient 371 371
No Patient Involvement 333 333
No Clinical Signs, Symptoms or Conditions 260 260
Device Embedded In Tissue or Plaque 116 116
Death 71 71
Foreign Body In Patient 48 49
No Information 36 36
Stroke/CVA 33 33
No Code Available 27 28
Renal Failure 26 26
Embolism 23 23
Myocardial Infarction 23 23
Low Blood Pressure/ Hypotension 22 22
Intracranial Hemorrhage 21 22
Vascular Dissection 19 19
Patient Problem/Medical Problem 19 19
Thrombus 18 18
Cardiac Tamponade 17 17
Hemorrhage/Bleeding 17 17
Bradycardia 17 17
Hemoptysis 15 15
Insufficient Information 15 15
Hemorrhage, Cerebral 14 14
Hemorrhage, Subarachnoid 14 14
Infarction, Cerebral 14 15
Hemolysis 12 12
Injury 12 12
Blood Loss 12 12
Pulmonary Embolism 12 12
Stenosis 10 10
Pain 10 10
Chest Pain 9 9
Cardiac Arrest 9 9
Hematoma 9 9
Perforation 9 9
Perforation of Vessels 9 9
Vessel Or Plaque, Device Embedded In 8 8
Transient Ischemic Attack 8 8
Vasoconstriction 8 8
Tachycardia 8 8
Heart Failure 8 8
Thromboembolism 8 8
Occlusion 7 7
High Blood Pressure/ Hypertension 7 7
Cardiopulmonary Arrest 6 6
Thrombosis 6 6
Dyspnea 5 5
Cardiogenic Shock 5 5
Nausea 5 5
Edema 4 4
Vomiting 4 4
Aneurysm 4 4
Air Embolism 4 4
Chills 4 4
Rupture 4 4
Loss of consciousness 4 4
Pericardial Effusion 4 4
Embolism/Embolus 3 3
Multiple Organ Failure 3 3
Fever 3 3
Inflammation 3 3
Ischemia 3 3
Ventricular Tachycardia 3 3
Discomfort 3 3
Cardiac Perforation 3 3
Obstruction/Occlusion 3 3
Embolus 3 3
Laceration(s) 3 3
Hypoxia 2 2
Seizures 2 2
Paralysis 2 2
Pneumothorax 2 2
Fistula 2 2
Headache 2 2
Intimal Dissection 2 2
Abdominal Pain 2 2
Anoxia 2 2
Arrhythmia 2 2
Ventilator Dependent 2 2
Pseudoaneurysm 2 2
Ventricular Fibrillation 2 2
Paresis 2 2
Failure of Implant 2 2
Extravasation 2 2
Anemia 2 2
Hematuria 2 2
Low Oxygen Saturation 2 2
Respiratory Failure 1 1
Atrial Perforation 1 1
Claudication 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Collapse 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Airway Obstruction 1 1
Calcium Deposits/Calcification 1 1
Congestive Heart Failure 1 1
Cyanosis 1 1
Fatigue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp I May-07-2020
2 Arrow International Inc II Sep-30-2016
3 Boston Scientific Corporation I Apr-18-2016
4 Edwards Lifesciences, LLC II Aug-26-2017
5 INARI MEDICAL II Jun-09-2020
6 LeMaitre Vascular, Inc. I Apr-01-2020
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