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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Definition Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Product CodeOCL
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 3
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 37 37
2021 63 63
2022 59 59
2023 99 99
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 252 252
Material Deformation 14 14
Break 13 13
Material Separation 9 9
Detachment of Device or Device Component 7 7
Material Puncture/Hole 6 6
Malposition of Device 4 4
Use of Device Problem 4 4
Material Fragmentation 4 4
No Flow 3 3
Insufficient Information 3 3
Separation Problem 3 3
Positioning Problem 2 2
High impedance 2 2
Fracture 2 2
Off-Label Use 2 2
Insufficient Flow or Under Infusion 2 2
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Smoking 1 1
Overheating of Device 1 1
Crack 1 1
Positioning Failure 1 1
Fire 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
Arrhythmia 45 45
Stroke/CVA 30 30
Hemorrhage/Bleeding 24 24
Cardiac Perforation 24 24
Pericardial Effusion 18 18
Blood Loss 14 14
Perforation 14 14
Tachycardia 13 13
Anemia 12 12
Hernia 11 11
Death 10 10
Cardiac Arrest 9 9
Pleural Effusion 8 8
Great Vessel Perforation 8 8
No Consequences Or Impact To Patient 7 7
Cardiac Tamponade 7 7
Low Blood Pressure/ Hypotension 7 7
Bradycardia 7 7
Atrial Fibrillation 6 6
Respiratory Failure 6 6
Complete Heart Block 5 5
Heart Block 5 5
Fistula 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Swelling/ Edema 4 4
Myocardial Infarction 4 4
No Known Impact Or Consequence To Patient 4 4
Low Oxygen Saturation 3 3
Lactate Dehydrogenase Increased 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
No Patient Involvement 3 3
Extubate 3 3
Vomiting 3 3
Perforation of Vessels 3 3
Pulmonary Edema 3 3
Shock 3 3
Dyspnea 3 3
Atrial Flutter 3 3
Pulmonary Embolism 2 2
Abdominal Pain 2 2
Chest Pain 2 2
Sepsis 2 2
Tissue Damage 2 2
Transient Ischemic Attack 2 2
Ulceration 2 2
Perforation of Esophagus 2 2
Discomfort 2 2
Vascular Dissection 2 2
No Code Available 1 1
Hematemesis 1 1
Melena 1 1
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1
Convulsion/Seizure 1 1
Ischemia Stroke 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Injury 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Visual Impairment 1 1
Dizziness 1 1
Dysphasia 1 1
Ulcer 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Renal Failure 1 1
ST Segment Elevation 1 1
Nausea 1 1
Inflammation 1 1
Dysphagia/ Odynophagia 1 1
Embolism 1 1
Hematoma 1 1
Burn(s) 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jun-26-2019
2 AtriCure, Inc. II Feb-14-2019
3 MEDTRONIC ATS MEDICAL, INC. II Nov-25-2020
4 Medtronic Perfusion Systems II May-25-2022
5 Medtronic Perfusion Systems II Nov-19-2021
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