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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
CROSS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 24 24
2020 55 55
2021 39 39
2022 70 70
2023 288 288
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 305 305
Failure to Advance 54 54
Difficult to Advance 42 42
Positioning Problem 37 37
Material Integrity Problem 21 21
Display or Visual Feedback Problem 19 19
Material Deformation 16 16
Insufficient Information 15 15
Burst Container or Vessel 15 15
Detachment of Device or Device Component 14 14
Device-Device Incompatibility 11 11
Use of Device Problem 9 9
Physical Resistance/Sticking 7 7
Defective Device 5 5
Break 5 5
Thermal Decomposition of Device 4 4
Deflation Problem 4 4
Material Frayed 4 4
Leak/Splash 4 4
Device Displays Incorrect Message 4 4
Difficult to Remove 4 4
Device Dislodged or Dislocated 4 4
Material Rupture 3 3
Deformation Due to Compressive Stress 3 3
Material Separation 2 2
Material Puncture/Hole 2 2
Device Markings/Labelling Problem 2 2
High impedance 2 2
Difficult to Insert 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Failure to Deliver Energy 2 2
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Unintended Movement 2 2
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Output below Specifications 1 1
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Entrapment of Device 1 1
Fracture 1 1
Contamination 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Fire 1 1
Patient-Device Incompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 214 214
No Clinical Signs, Symptoms or Conditions 117 117
Cardiac Tamponade 110 110
Low Blood Pressure/ Hypotension 84 84
Cardiac Perforation 46 46
Thrombosis/Thrombus 39 39
Perforation 32 32
Perforation of Vessels 25 25
Hematoma 22 22
Hemorrhage/Bleeding 16 16
Cardiac Arrest 16 16
No Consequences Or Impact To Patient 15 15
Air Embolism 10 10
Arrhythmia 9 9
Stroke/CVA 9 9
Death 7 7
Non specific EKG/ECG Changes 6 6
Asystole 6 6
Foreign Body In Patient 5 5
Tachycardia 5 5
Chest Pain 5 5
Dyspnea 5 5
Bradycardia 5 5
Insufficient Information 5 5
Fistula 4 4
Hemothorax 4 4
High Blood Pressure/ Hypertension 4 4
Pseudoaneurysm 4 4
Ventricular Fibrillation 4 4
No Known Impact Or Consequence To Patient 4 4
Heart Block 4 4
Respiratory Arrest 4 4
Embolism/Embolus 4 4
Transient Ischemic Attack 3 3
Hypoxia 3 3
Burn(s) 3 3
Atrial Fibrillation 2 2
Embolism 2 2
Intracranial Hemorrhage 2 2
Hemoptysis 2 2
Shock 2 2
Pleural Effusion 2 2
Diaphoresis 2 2
Thromboembolism 2 2
Electric Shock 2 2
Swelling/ Edema 2 2
Pericarditis 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
No Code Available 1 1
Unspecified Vascular Problem 1 1
Ischemia Stroke 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Rupture 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Low Cardiac Output 1 1
Vomiting 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Hypothermia 1 1
Ischemia 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Pain 1 1
Hypopyon 1 1
Hypersensitivity/Allergic reaction 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Infarction, Cerebral 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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