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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, septostomy
Regulation Description Septostomy catheter.
Product CodeDXF
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRAVERSE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
CROSS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 55 55
2021 39 39
2022 70 70
2023 288 288
2024 368 368
2025 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 430 430
Failure to Advance 99 99
Difficult to Advance 85 85
Display or Visual Feedback Problem 62 62
Positioning Problem 54 54
Material Integrity Problem 50 50
Material Deformation 41 41
Detachment of Device or Device Component 25 25
Use of Device Problem 24 24
Physical Resistance/Sticking 21 21
Device-Device Incompatibility 17 17
Insufficient Information 14 14
Burst Container or Vessel 14 14
Defective Device 11 11
Difficult to Remove 10 10
Material Frayed 10 10
Device Dislodged or Dislocated 8 8
Thermal Decomposition of Device 8 8
Contamination 6 6
Packaging Problem 5 5
Unsealed Device Packaging 4 4
Device Displays Incorrect Message 4 4
Deformation Due to Compressive Stress 4 4
Material Rupture 4 4
Break 4 4
Difficult to Insert 4 4
Device Contaminated During Manufacture or Shipping 3 3
Obstruction of Flow 3 3
Tear, Rip or Hole in Device Packaging 3 3
Leak/Splash 3 3
Device Markings/Labelling Problem 2 2
Failure to Deliver Energy 2 2
Difficult or Delayed Positioning 2 2
Device Contamination with Chemical or Other Material 2 2
High impedance 2 2
Fracture 2 2
Unintended Movement 2 2
Positioning Failure 2 2
Material Puncture/Hole 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanics Altered 1 1
Off-Label Use 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Fire 1 1
Output below Specifications 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Communication or Transmission Problem 1 1
Entrapment of Device 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 386 386
No Clinical Signs, Symptoms or Conditions 226 226
Low Blood Pressure/ Hypotension 176 176
Cardiac Tamponade 171 171
Cardiac Perforation 123 123
Thrombosis/Thrombus 57 57
Perforation of Vessels 42 42
Perforation 34 34
Hematoma 31 31
Cardiac Arrest 28 28
Hemorrhage/Bleeding 23 23
Arrhythmia 14 14
Stroke/CVA 13 13
Bradycardia 12 12
Tachycardia 12 12
Air Embolism 11 11
No Consequences Or Impact To Patient 10 10
Chest Pain 9 9
Asystole 8 8
Hemothorax 6 6
Non specific EKG/ECG Changes 6 6
Dyspnea 6 6
Insufficient Information 5 5
High Blood Pressure/ Hypertension 5 5
Foreign Body In Patient 5 5
Vascular Dissection 5 5
Fistula 5 5
Heart Block 5 5
Atrial Fibrillation 5 5
Death 4 4
Ventricular Fibrillation 4 4
Pleural Effusion 4 4
Pseudoaneurysm 4 4
Respiratory Arrest 4 4
Embolism/Embolus 4 4
Hypoxia 3 3
Transient Ischemic Attack 3 3
Intracranial Hemorrhage 3 3
Burn(s) 3 3
Diminished Pulse Pressure 2 2
Pain 2 2
Swelling/ Edema 2 2
Ischemia 2 2
Shock 2 2
Electric Shock 2 2
Thromboembolism 2 2
Needle Stick/Puncture 2 2
Diaphoresis 2 2
Loss of consciousness 2 2
Hemoptysis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular I Oct-16-2020
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