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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, septostomy
Product CodeDXF
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 36 36
2019 24 24
2020 55 55
2021 39 39
2022 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 160 160
Burst Container or Vessel 22 22
Insufficient Information 8 8
Deflation Problem 6 6
Detachment of Device or Device Component 5 5
Material Rupture 5 5
Break 4 4
Leak/Splash 4 4
Improper or Incorrect Procedure or Method 3 3
Material Separation 3 3
Deformation Due to Compressive Stress 3 3
Material Puncture/Hole 2 2
Packaging Problem 2 2
High impedance 2 2
Material Deformation 2 2
Failure to Fire 1 1
Device-Device Incompatibility 1 1
Failure to Deliver Energy 1 1
Fracture 1 1
Inflation Problem 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Device Damaged Prior to Use 1 1
Device Displays Incorrect Message 1 1
Entrapment of Device 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Mechanical Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 71 71
Cardiac Tamponade 47 47
No Consequences Or Impact To Patient 26 26
No Clinical Signs, Symptoms or Conditions 22 22
No Known Impact Or Consequence To Patient 12 12
Perforation 11 11
Thrombosis/Thrombus 8 8
Stroke/CVA 8 8
Death 7 7
Hematoma 6 6
Cardiac Perforation 6 6
Embolism/Embolus 4 4
Pseudoaneurysm 4 4
Foreign Body In Patient 4 4
Transient Ischemic Attack 3 3
Hemothorax 3 3
Perforation of Vessels 3 3
Insufficient Information 3 3
Pericarditis 2 2
Device Embedded In Tissue or Plaque 2 2
Embolism 2 2
Fistula 2 2
Tachycardia 2 2
Low Blood Pressure/ Hypotension 2 2
Hemorrhage/Bleeding 2 2
Heart Block 2 2
Thromboembolism 2 2
Hemoptysis 1 1
Infarction, Cerebral 1 1
Arrhythmia 1 1
Bradycardia 1 1
No Code Available 1 1
Complete Heart Block 1 1
Dyspnea 1 1
Cardiac Arrest 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Ischemia Stroke 1 1
Nerve Damage 1 1
Pneumothorax 1 1
Cough 1 1
Unspecified Vascular Problem 1 1
Pulmonary Valve Stenosis 1 1
Thrombus 1 1
Air Embolism 1 1
High Blood Pressure/ Hypertension 1 1
Vascular Dissection 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC I Apr-25-2019
2 Medtronic Vascular I Oct-16-2020
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