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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
ATRAVERSE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 328 328
Failure to Advance 65 65
Difficult to Advance 49 49
Positioning Problem 40 40
Display or Visual Feedback Problem 24 24
Material Integrity Problem 22 22
Material Deformation 20 20
Detachment of Device or Device Component 16 16
Burst Container or Vessel 15 15
Insufficient Information 15 15
Device-Device Incompatibility 14 14
Use of Device Problem 11 11
Physical Resistance/Sticking 9 9
Difficult to Remove 5 5
Defective Device 5 5
Break 5 5
Material Frayed 5 5
Deflation Problem 4 4
Leak/Splash 4 4
Thermal Decomposition of Device 4 4
Device Displays Incorrect Message 4 4
Device Dislodged or Dislocated 4 4
Deformation Due to Compressive Stress 3 3
Material Rupture 3 3
Obstruction of Flow 3 3
Material Puncture/Hole 2 2
Material Separation 2 2
Device Markings/Labelling Problem 2 2
Contamination 2 2
Failure to Deliver Energy 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
High impedance 2 2
Difficult to Insert 2 2
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Unintended Movement 2 2
No Apparent Adverse Event 1 1
Output below Specifications 1 1
Appropriate Term/Code Not Available 1 1
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Fracture 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
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 244 244
No Clinical Signs, Symptoms or Conditions 133 133
Cardiac Tamponade 119 119
Low Blood Pressure/ Hypotension 101 101
Cardiac Perforation 61 61
Thrombosis/Thrombus 41 41
Perforation 32 32
Perforation of Vessels 29 29
Hematoma 26 26
Hemorrhage/Bleeding 18 18
Cardiac Arrest 17 17
No Consequences Or Impact To Patient 15 15
Air Embolism 11 11
Arrhythmia 10 10
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
Dyspnea 5 5
Chest Pain 5 5
Bradycardia 5 5
Insufficient Information 5 5
Respiratory Arrest 4 4
Fistula 4 4
Hemothorax 4 4
High Blood Pressure/ Hypertension 4 4
Ventricular Fibrillation 4 4
No Known Impact Or Consequence To Patient 4 4
Pseudoaneurysm 4 4
Heart Block 4 4
Embolism/Embolus 4 4
Transient Ischemic Attack 3 3
Hypoxia 3 3
Burn(s) 3 3
Atrial Fibrillation 3 3
Hemoptysis 2 2
Embolism 2 2
Pleural Effusion 2 2
Intracranial Hemorrhage 2 2
Shock 2 2
Electric Shock 2 2
Diaphoresis 2 2
Needle Stick/Puncture 2 2
Thromboembolism 2 2
Pericarditis 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Swelling/ Edema 2 2
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
No Code Available 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Ischemia Stroke 1 1
Low White Blood Cell Count 1 1
Cough 1 1
Unspecified Vascular Problem 1 1
Respiratory Failure 1 1
Low Cardiac Output 1 1
Loss of consciousness 1 1
Rupture 1 1
Vomiting 1 1
Hypersensitivity/Allergic reaction 1 1
Hypopyon 1 1
Hypothermia 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Ischemia 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Pain 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Pulmonary Embolism 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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