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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
2023 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 259 259
Failure to Advance 28 28
Burst Container or Vessel 22 22
Difficult to Advance 15 15
Insufficient Information 15 15
Detachment of Device or Device Component 10 10
Material Deformation 8 8
Material Integrity Problem 7 7
Positioning Problem 7 7
Deflation Problem 6 6
Leak/Splash 5 5
Break 5 5
Display or Visual Feedback Problem 5 5
Device-Device Incompatibility 5 5
Material Rupture 5 5
Physical Resistance/Sticking 5 5
Packaging Problem 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Material Separation 3 3
Deformation Due to Compressive Stress 3 3
Thermal Decomposition of Device 3 3
Difficult to Remove 3 3
Unintended Movement 2 2
Device Dislodged or Dislocated 2 2
Mechanical Problem 2 2
Material Frayed 2 2
High impedance 2 2
Positioning Failure 2 2
Material Puncture/Hole 2 2
Device Damaged Prior to Use 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or Separation Problem 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Failure to Fire 1 1
Patient-Device Incompatibility 1 1
Inflation Problem 1 1
Difficult or Delayed Positioning 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Contamination 1 1
Failure to Deliver Energy 1 1
Entrapment of Device 1 1
Fracture 1 1
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Close 1 1
Output below Specifications 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 162 162
Cardiac Tamponade 84 84
No Clinical Signs, Symptoms or Conditions 65 65
Low Blood Pressure/ Hypotension 44 44
No Consequences Or Impact To Patient 26 26
Thrombosis/Thrombus 25 25
Cardiac Perforation 22 22
Perforation 22 22
No Known Impact Or Consequence To Patient 12 12
Perforation of Vessels 12 12
Hematoma 11 11
Stroke/CVA 8 8
Arrhythmia 7 7
Hemorrhage/Bleeding 7 7
Death 7 7
Cardiac Arrest 5 5
Foreign Body In Patient 5 5
Insufficient Information 5 5
Heart Block 4 4
Embolism/Embolus 4 4
Pseudoaneurysm 4 4
Bradycardia 4 4
Air Embolism 3 3
Chest Pain 3 3
Hemothorax 3 3
Tachycardia 3 3
Fistula 3 3
Transient Ischemic Attack 3 3
Diaphoresis 2 2
High Blood Pressure/ Hypertension 2 2
Hypoxia 2 2
Atrial Fibrillation 2 2
Dyspnea 2 2
Embolism 2 2
Intracranial Hemorrhage 2 2
Hemoptysis 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Thromboembolism 2 2
Pericarditis 2 2
Asystole 2 2
Respiratory Arrest 2 2
Cough 1 1
Ischemia Stroke 1 1
Unspecified Vascular Problem 1 1
No Code Available 1 1
Complete Heart Block 1 1
Electric Shock 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Infarction, Cerebral 1 1
Nerve Damage 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Hypopyon 1 1
Hypersensitivity/Allergic reaction 1 1
Rupture 1 1
Thrombus 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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