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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 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 335 335
Failure to Advance 66 66
Difficult to Advance 52 52
Positioning Problem 40 40
Display or Visual Feedback Problem 28 28
Material Deformation 23 23
Material Integrity Problem 23 23
Detachment of Device or Device Component 17 17
Burst Container or Vessel 15 15
Insufficient Information 15 15
Device-Device Incompatibility 14 14
Use of Device Problem 12 12
Physical Resistance/Sticking 9 9
Material Frayed 6 6
Break 5 5
Difficult to Remove 5 5
Defective Device 5 5
Device Displays Incorrect Message 4 4
Thermal Decomposition of Device 4 4
Deflation Problem 4 4
Leak/Splash 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
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
High impedance 2 2
Difficult to Insert 2 2
Contamination 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
Output below Specifications 1 1
Appropriate Term/Code Not Available 1 1
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Entrapment of Device 1 1
Fracture 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
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 253 253
No Clinical Signs, Symptoms or Conditions 137 137
Cardiac Tamponade 122 122
Low Blood Pressure/ Hypotension 109 109
Cardiac Perforation 70 70
Thrombosis/Thrombus 41 41
Perforation 32 32
Perforation of Vessels 29 29
Hematoma 27 27
Hemorrhage/Bleeding 18 18
Cardiac Arrest 17 17
No Consequences Or Impact To Patient 15 15
Air Embolism 11 11
Arrhythmia 11 11
Stroke/CVA 9 9
Chest Pain 8 8
Death 7 7
Bradycardia 6 6
Non specific EKG/ECG Changes 6 6
Asystole 6 6
Foreign Body In Patient 5 5
Tachycardia 5 5
Dyspnea 5 5
Insufficient Information 5 5
Embolism/Embolus 4 4
Atrial Fibrillation 4 4
Fistula 4 4
Hemothorax 4 4
High Blood Pressure/ Hypertension 4 4
Pseudoaneurysm 4 4
No Known Impact Or Consequence To Patient 4 4
Ventricular Fibrillation 4 4
Heart Block 4 4
Respiratory Arrest 4 4
Transient Ischemic Attack 3 3
Hypoxia 3 3
Burn(s) 3 3
Embolism 2 2
Intracranial Hemorrhage 2 2
Hemoptysis 2 2
Shock 2 2
Pleural Effusion 2 2
Diminished Pulse Pressure 2 2
Electric Shock 2 2
Diaphoresis 2 2
Needle Stick/Puncture 2 2
Pericarditis 2 2
Thromboembolism 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Swelling/ Edema 2 2
No Code Available 1 1
Ischemia Stroke 1 1
Low White Blood Cell Count 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
Unspecified Vascular Problem 1 1
Respiratory Failure 1 1
Low Cardiac Output 1 1
Complete Heart Block 1 1
Vomiting 1 1
Rupture 1 1
Loss of consciousness 1 1
Pneumothorax 1 1
Pulmonary Edema 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
Pulmonary Embolism 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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