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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

MDR Year MDR Reports MDR Events
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 471 471
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 171 171
Material Puncture/Hole 139 139
Fluid/Blood Leak 138 138
Mechanical Problem 138 138
Adverse Event Without Identified Device or Use Problem 130 130
Crack 127 127
Material Separation 89 89
Obstruction of Flow 52 52
Break 51 51
Detachment of Device or Device Component 46 46
Disconnection 41 41
Leak/Splash 38 38
Fracture 36 36
Material Twisted/Bent 24 24
Insufficient Information 24 24
Packaging Problem 23 23
Air/Gas in Device 20 20
Material Split, Cut or Torn 19 19
Loss of or Failure to Bond 18 18
Nonstandard Device 17 17
Gas/Air Leak 13 13
Migration 13 13
Misassembled During Installation 11 11
Difficult to Insert 11 11
Device Markings/Labelling Problem 10 10
Improper Flow or Infusion 9 9
Defective Component 9 9
Component Missing 8 8
Material Rupture 8 8
Defective Device 7 7
Device Contamination with Chemical or Other Material 7 7
Deformation Due to Compressive Stress 7 7
Increase in Pressure 7 7
Coagulation in Device or Device Ingredient 6 6
No Flow 6 6
Material Integrity Problem 6 6
Contamination 6 6
Infusion or Flow Problem 6 6
Ejection Problem 6 6
Loose or Intermittent Connection 6 6
Restricted Flow rate 5 5
Malposition of Device 5 5
Positioning Problem 5 5
Physical Resistance/Sticking 5 5
Device Handling Problem 5 5
Positioning Failure 5 5
Unsealed Device Packaging 5 5
Material Discolored 5 5
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Therapeutic or Diagnostic Output Failure 4 4
Contamination /Decontamination Problem 4 4
Delivered as Unsterile Product 4 4
Inflation Problem 4 4
Difficult to Remove 4 4
Partial Blockage 4 4
Unintended Movement 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Advance 3 3
Free or Unrestricted Flow 3 3
Device Slipped 3 3
Material Too Soft/Flexible 3 3
Off-Label Use 3 3
Complete Blockage 3 3
Burst Container or Vessel 3 3
Tear, Rip or Hole in Device Packaging 3 3
Backflow 3 3
Connection Problem 3 3
No Apparent Adverse Event 3 3
Use of Device Problem 3 3
Deflation Problem 2 2
Particulates 2 2
Device Difficult to Setup or Prepare 2 2
Device Dislodged or Dislocated 2 2
Unraveled Material 2 2
Device Displays Incorrect Message 2 2
Explosion 2 2
Product Quality Problem 2 2
Decoupling 2 2
Inaccurate Flow Rate 2 2
Failure to Advance 2 2
Protective Measures Problem 2 2
Material Too Rigid or Stiff 2 2
Patient Device Interaction Problem 2 2
Material Fragmentation 2 2
Inadequacy of Device Shape and/or Size 2 2
Collapse 2 2
Separation Problem 2 2
Insufficient Flow or Under Infusion 2 2
Premature Separation 2 2
Entrapment of Device 2 2
Failure to Disconnect 1 1
Material Erosion 1 1
Sharp Edges 1 1
Noise, Audible 1 1
Material Perforation 1 1
Failure to Align 1 1
Temperature Problem 1 1
Gel Leak 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 727 727
Hemorrhage/Bleeding 115 115
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
Exsanguination 18 18
Perforation of Vessels 17 17
Thrombosis/Thrombus 17 17
Hematoma 16 16
Air Embolism 14 14
Low Blood Pressure/ Hypotension 13 13
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
Obstruction/Occlusion 8 8
Swelling/ Edema 8 8
Vascular Dissection 8 8
Sepsis 7 7
Hypovolemia 6 6
Respiratory Failure 6 6
Unspecified Infection 6 6
Hemolysis 6 6
Bradycardia 6 6
Stroke/CVA 5 5
Pulmonary Embolism 5 5
Hypoxia 5 5
Foreign Body In Patient 5 5
No Code Available 4 4
Multiple Organ Failure 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Laceration(s) 4 4
Bacterial Infection 4 4
Decreased Respiratory Rate 4 4
Bronchopneumonia 4 4
Rupture 4 4
Brain Injury 3 3
Low Oxygen Saturation 3 3
Venipuncture 3 3
Pulmonary Hypertension 3 3
Unspecified Tissue Injury 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
Aortic Dissection 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Pneumothorax 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
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
Pulmonary Dysfunction 1 1
Pulmonary Edema 1 1
Renal Failure 1 1
Scar Tissue 1 1
Septic Shock 1 1
Swelling 1 1
Tachycardia 1 1
Thrombosis 1 1
Tissue Damage 1 1
Ulceration 1 1
Ulcer 1 1
Hemolytic Anemia 1 1
Distress 1 1
Sedation 1 1
Numbness 1 1
Loss of consciousness 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

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 Mar-19-2024
9 Medtronic Perfusion Systems II Jan-12-2022
10 Medtronic Perfusion Systems II Oct-01-2021
11 Medtronic Perfusion Systems II Jun-16-2021
12 OriGen Biomedical, Inc. I Jun-04-2019
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