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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
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 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 360 360
Failure to Advance 54 54
Difficult to Advance 43 43
Positioning Problem 37 37
Burst Container or Vessel 23 23
Material Integrity Problem 21 21
Display or Visual Feedback Problem 19 19
Insufficient Information 17 17
Material Deformation 16 16
Detachment of Device or Device Component 15 15
Device-Device Incompatibility 11 11
Deflation Problem 9 9
Use of Device Problem 9 9
Material Rupture 8 8
Physical Resistance/Sticking 7 7
Break 6 6
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
Material Frayed 4 4
Thermal Decomposition of Device 4 4
Material Separation 3 3
Peeled/Delaminated 3 3
Improper or Incorrect Procedure or Method 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
Failure to Deliver Energy 2 2
Entrapment of Device 2 2
High impedance 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Difficult to Insert 2 2
Partial Blockage 1 1
Loose or Intermittent Connection 1 1
Inflation Problem 1 1
Fracture 1 1
Contamination 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
Obstruction of Flow 1 1
Failure to Fire 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 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
Electromagnetic Compatibility Problem 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Close 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 241 241
Cardiac Tamponade 121 121
No Clinical Signs, Symptoms or Conditions 117 117
Low Blood Pressure/ Hypotension 84 84
Cardiac Perforation 49 49
Thrombosis/Thrombus 39 39
No Consequences Or Impact To Patient 38 38
Perforation 34 34
Perforation of Vessels 25 25
Hematoma 24 24
Hemorrhage/Bleeding 17 17
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
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 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
Needle Stick/Puncture 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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