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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
BAYLIS MEDICAL COMPANY INC.
  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
2014 4 4
2015 21 21
2016 13 13
2017 13 13
2018 36 36
2019 24 24
2020 55 55
2021 39 39
2022 70 70
2023 288 288
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 369 369
Failure to Advance 57 57
Difficult to Advance 47 47
Positioning Problem 38 38
Burst Container or Vessel 23 23
Material Integrity Problem 22 22
Display or Visual Feedback Problem 20 20
Material Deformation 18 18
Insufficient Information 17 17
Detachment of Device or Device Component 15 15
Device-Device Incompatibility 12 12
Deflation Problem 9 9
Use of Device Problem 9 9
Material Rupture 8 8
Physical Resistance/Sticking 8 8
Break 6 6
Material Frayed 5 5
Leak/Splash 5 5
Defective Device 5 5
Device Displays Incorrect Message 5 5
Packaging Problem 5 5
Device Dislodged or Dislocated 4 4
Difficult to Remove 4 4
Thermal Decomposition of Device 4 4
Material Separation 3 3
Peeled/Delaminated 3 3
Improper or Incorrect Procedure or Method 3 3
Obstruction of Flow 3 3
Deformation Due to Compressive Stress 3 3
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unintended Movement 2 2
Mechanical Problem 2 2
Material Puncture/Hole 2 2
Detachment Of Device Component 2 2
Contamination 2 2
Failure to Deliver Energy 2 2
Entrapment of Device 2 2
Difficult to Insert 2 2
High impedance 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Inflation Problem 1 1
Partial Blockage 1 1
Loose or Intermittent Connection 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Fire 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Output below Specifications 1 1
Device Operates Differently Than Expected 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 252 252
No Clinical Signs, Symptoms or Conditions 127 127
Cardiac Tamponade 124 124
Low Blood Pressure/ Hypotension 90 90
Cardiac Perforation 55 55
Thrombosis/Thrombus 39 39
No Consequences Or Impact To Patient 38 38
Perforation 34 34
Hematoma 25 25
Perforation of Vessels 25 25
Hemorrhage/Bleeding 19 19
No Known Impact Or Consequence To Patient 17 17
Cardiac Arrest 16 16
Stroke/CVA 13 13
Air Embolism 10 10
Arrhythmia 9 9
Death 8 8
Pseudoaneurysm 7 7
Foreign Body In Patient 6 6
Asystole 6 6
Tachycardia 6 6
Non specific EKG/ECG Changes 6 6
Dyspnea 5 5
Bradycardia 5 5
Chest Pain 5 5
Thrombus 5 5
Transient Ischemic Attack 5 5
Insufficient Information 5 5
Respiratory Arrest 4 4
Ventricular Fibrillation 4 4
Heart Block 4 4
Embolism/Embolus 4 4
Fistula 4 4
Hemothorax 4 4
High Blood Pressure/ Hypertension 4 4
Hypoxia 3 3
Burn(s) 3 3
Thromboembolism 3 3
Ventricular Tachycardia 3 3
Pain 2 2
Shock 2 2
Electric Shock 2 2
Stenosis 2 2
Diaphoresis 2 2
Needle Stick/Puncture 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Pericarditis 2 2
Atrial Fibrillation 2 2
Pulmonary Embolism 2 2
Hemoptysis 2 2
Embolism 2 2
Ischemia 2 2
Pleural Effusion 2 2
Intracranial Hemorrhage 2 2
Swelling/ Edema 2 2
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
Unspecified Vascular Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Hypopyon 1 1
Hypothermia 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Infarction, Cerebral 1 1
Cough 1 1
Ischemia Stroke 1 1
No Information 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Respiratory Failure 1 1
Low Cardiac Output 1 1
Hematuria 1 1
Rupture 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baylis Medical Corp * II Nov-10-2016
2 Edwards Lifesciences, LLC I Apr-25-2019
3 Medtronic Vascular I Oct-16-2020
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