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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 1

MDR Year MDR Reports MDR Events
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 471 471
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 159 159
Material Puncture/Hole 133 133
Fluid/Blood Leak 132 132
Adverse Event Without Identified Device or Use Problem 128 128
Crack 125 125
Mechanical Problem 122 122
Material Separation 88 88
Obstruction of Flow 50 50
Break 48 48
Detachment of Device or Device Component 45 45
Disconnection 39 39
Leak/Splash 36 36
Fracture 36 36
Material Twisted/Bent 24 24
Insufficient Information 24 24
Packaging Problem 22 22
Air/Gas in Device 20 20
Loss of or Failure to Bond 18 18
Nonstandard Device 17 17
Material Split, Cut or Torn 17 17
Migration 13 13
Gas/Air Leak 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
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
Loose or Intermittent Connection 6 6
Contamination 6 6
Coagulation in Device or Device Ingredient 6 6
Positioning Failure 5 5
Material Discolored 5 5
Unsealed Device Packaging 5 5
Restricted Flow rate 5 5
Malposition of Device 5 5
Improper or Incorrect Procedure or Method 5 5
Physical Resistance/Sticking 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
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Remove 4 4
Contamination /Decontamination Problem 4 4
Inflation Problem 4 4
Delivered as Unsterile Product 4 4
Partial Blockage 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
Tear, Rip or Hole in Device Packaging 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
Material Too Soft/Flexible 3 3
Patient Device Interaction Problem 2 2
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
Failure to Advance 2 2
Device Displays Incorrect Message 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
Data Back-Up Problem 1 1
Activation, Positioning or Separation Problem 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 686 686
Hemorrhage/Bleeding 114 114
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
Thrombosis/Thrombus 17 17
Perforation of Vessels 17 17
Exsanguination 16 16
Hematoma 16 16
Air Embolism 14 14
Low Blood Pressure/ Hypotension 13 13
Ischemia 13 13
Cardiac Perforation 12 12
No Patient Involvement 11 11
Cardiac Tamponade 11 11
Perforation 10 10
Device Embedded In Tissue or Plaque 10 10
Swelling/ Edema 8 8
Obstruction/Occlusion 8 8
Vascular Dissection 8 8
Sepsis 7 7
Bradycardia 6 6
Hemolysis 6 6
Respiratory Failure 6 6
Hypovolemia 6 6
Unspecified Infection 6 6
Hypoxia 5 5
Stroke/CVA 5 5
Foreign Body In Patient 5 5
Pulmonary Embolism 5 5
Multiple Organ Failure 4 4
No Code Available 4 4
Decreased Respiratory Rate 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Laceration(s) 4 4
Bacterial Infection 4 4
Bronchopneumonia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Rupture 4 4
Venipuncture 3 3
Low Oxygen Saturation 3 3
Pulmonary Hypertension 3 3
Brain Injury 3 3
Arrhythmia 2 2
Asystole 2 2
Embolism/Embolus 2 2
Endocarditis 2 2
Aortic Dissection 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Extravasation 2 2
Non specific EKG/ECG Changes 2 2
Airway Obstruction 2 2
Pericardial Effusion 2 2
Sudden Cardiac Death 2 2
Patient Problem/Medical Problem 2 2
Atrial Perforation 2 2
Pneumothorax 2 2
Pain 2 2
Cardiopulmonary Arrest 2 2
High Blood Pressure/ Hypertension 1 1
Numbness 1 1
Aneurysm 1 1
Ventricular Fibrillation 1 1
Distress 1 1
Hemolytic Anemia 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Chest Pain 1 1
Pneumonia 1 1
Dyspnea 1 1
Neurological Deficit/Dysfunction 1 1
Renal Failure 1 1
Unspecified Heart Problem 1 1
Ulceration 1 1
Loss of consciousness 1 1
Thromboembolism 1 1
Tingling 1 1
Pulmonary Edema 1 1
Blurred Vision 1 1
Respiratory Insufficiency 1 1
Hyperbilirubinemia 1 1
Failure of Implant 1 1
Cough 1 1
Heart Failure/Congestive Heart Failure 1 1
Ulcer 1 1
Pleural Effusion 1 1
Scar Tissue 1 1
Myocardial Contusion 1 1
Tachycardia 1 1
Convulsion/Seizure 1 1
Atrial Flutter 1 1
Swelling 1 1
Sedation 1 1
Septic Shock 1 1
Complete Heart Block 1 1
Thrombosis 1 1
Intracranial Hemorrhage 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 Jan-12-2022
9 Medtronic Perfusion Systems II Oct-01-2021
10 Medtronic Perfusion Systems II Jun-16-2021
11 OriGen Biomedical, Inc. I Jun-04-2019
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