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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, cannula and tubing, vascular, cardiopulmonary bypass
Product CodeDWF
Regulation Number 870.4210
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOGARD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
KAPP SURGICAL INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 471 471
2024 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 188 188
Mechanical Problem 161 161
Fluid/Blood Leak 148 148
Material Puncture/Hole 146 146
Crack 141 141
Adverse Event Without Identified Device or Use Problem 133 133
Material Separation 101 101
Obstruction of Flow 58 58
Break 54 54
Detachment of Device or Device Component 46 46
Disconnection 42 42
Leak/Splash 40 40
Fracture 38 38
Insufficient Information 26 26
Material Twisted/Bent 25 25
Packaging Problem 24 24
Air/Gas in Device 22 22
Material Split, Cut or Torn 19 19
Loss of or Failure to Bond 18 18
Nonstandard Device 17 17
Migration 13 13
Gas/Air Leak 13 13
Misassembled During Installation 12 12
Difficult to Insert 11 11
Contamination 10 10
Device Markings/Labelling Problem 10 10
Improper Flow or Infusion 9 9
Defective Component 9 9
Component Missing 8 8
Material Rupture 8 8
Increase in Pressure 7 7
Defective Device 7 7
Deformation Due to Compressive Stress 7 7
Device Contamination with Chemical or Other Material 7 7
Infusion or Flow Problem 6 6
No Flow 6 6
Material Integrity Problem 6 6
Ejection Problem 6 6
Physical Resistance/Sticking 6 6
Coagulation in Device or Device Ingredient 6 6
Loose or Intermittent Connection 6 6
Unsealed Device Packaging 5 5
Restricted Flow rate 5 5
Positioning Failure 5 5
Material Discolored 5 5
Malposition of Device 5 5
Improper or Incorrect Procedure or Method 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Handling Problem 5 5
Positioning Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Difficult to Remove 4 4
Contamination /Decontamination Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Partial Blockage 4 4
Inflation Problem 4 4
Delivered as Unsterile Product 4 4
Backflow 3 3
Burst Container or Vessel 3 3
Complete Blockage 3 3
Connection Problem 3 3
Use of Device Problem 3 3
Off-Label Use 3 3
Device Slipped 3 3
No Apparent Adverse Event 3 3
Free or Unrestricted Flow 3 3
Difficult to Advance 3 3
Patient Device Interaction Problem 3 3
Material Too Soft/Flexible 3 3
Separation Problem 2 2
Premature Separation 2 2
Device Dislodged or Dislocated 2 2
Explosion 2 2
Protective Measures Problem 2 2
Unraveled Material 2 2
Inadequacy of Device Shape and/or Size 2 2
Insufficient Flow or Under Infusion 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 2 2
Device Displays Incorrect Message 2 2
Failure to Advance 2 2
Collapse 2 2
Decoupling 2 2
Deflation Problem 2 2
Entrapment of Device 2 2
Particulates 2 2
Device Difficult to Setup or Prepare 2 2
Inaccurate Flow Rate 2 2
Material Fragmentation 2 2
Gel Leak 1 1
Incorrect Measurement 1 1
Melted 1 1
Misassembled 1 1
Material Erosion 1 1
Display or Visual Feedback Problem 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 795 795
Hemorrhage/Bleeding 123 123
No Known Impact Or Consequence To Patient 111 111
No Consequences Or Impact To Patient 57 57
Blood Loss 36 36
Insufficient Information 34 34
Death 27 27
Cardiac Arrest 25 25
Perforation of Vessels 22 22
Exsanguination 18 18
Thrombosis/Thrombus 18 18
Hematoma 16 16
Low Blood Pressure/ Hypotension 15 15
Air Embolism 14 14
Ischemia 13 13
Cardiac Perforation 12 12
Cardiac Tamponade 11 11
No Patient Involvement 11 11
Device Embedded In Tissue or Plaque 10 10
Perforation 10 10
Vascular Dissection 9 9
Swelling/ Edema 8 8
Obstruction/Occlusion 8 8
Sepsis 7 7
Unspecified Infection 7 7
Foreign Body In Patient 7 7
Hemolysis 6 6
Bradycardia 6 6
Stroke/CVA 6 6
Hypovolemia 6 6
Respiratory Failure 6 6
Rupture 5 5
Pulmonary Embolism 5 5
Hypoxia 5 5
Laceration(s) 4 4
Bacterial Infection 4 4
Brain Injury 4 4
Bronchopneumonia 4 4
Decreased Respiratory Rate 4 4
No Code Available 4 4
Multiple Organ Failure 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Pulmonary Hypertension 3 3
Unspecified Tissue Injury 3 3
Low Oxygen Saturation 3 3
Venipuncture 3 3
Pulmonary Edema 3 3
Pneumothorax 2 2
Aortic Dissection 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Airway Obstruction 2 2
Arrhythmia 2 2
Cardiopulmonary Arrest 2 2
Non specific EKG/ECG Changes 2 2
Endocarditis 2 2
Pain 2 2
Extravasation 2 2
Foreign Body Reaction 2 2
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Asystole 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Thrombocytopenia 2 2
Embolism/Embolus 2 2
Heart Failure/Congestive Heart Failure 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Thromboembolism 1 1
Convulsion/Seizure 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Gastrointestinal Hemorrhage 1 1
Renal Impairment 1 1
Skin Infection 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Intracranial Hemorrhage 1 1
Hyperbilirubinemia 1 1
High Blood Pressure/ Hypertension 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Neurological Deficit/Dysfunction 1 1
Failure of Implant 1 1
Dyspnea 1 1
Chest Pain 1 1
Atrial Flutter 1 1
Aneurysm 1 1
Myocardial Contusion 1 1
Vascular System (Circulation), Impaired 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Blurred Vision 1 1
Tingling 1 1
Pulmonary Dysfunction 1 1
Renal Failure 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc III Nov-29-2021
2 Cardiac Assist, Inc II Feb-07-2020
3 Edwards Lifesciences, LLC II Jan-10-2020
4 Edwards Lifesciences, LLC II Nov-18-2019
5 LivaNova USA II Jan-23-2019
6 LivaNova USA Inc. II Jun-26-2020
7 Maquet Cardiovascular, LLC II May-31-2019
8 Medtronic Perfusion Systems II May-10-2024
9 Medtronic Perfusion Systems II Mar-19-2024
10 Medtronic Perfusion Systems II Jan-12-2022
11 Medtronic Perfusion Systems II Oct-01-2021
12 Medtronic Perfusion Systems II Jun-16-2021
13 OriGen Biomedical, Inc. I Jun-04-2019
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