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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device catheter, intravascular occluding, temporary
Product CodeMJN
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
ABIOMED INC.
  SE - WITH LIMITATIONS 1
ARCH CATHETER, LLC
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRONT LINE MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
NEURESCUE APS
  SUBSTANTIALLY EQUIVALENT 1
PRYTIME MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
PRYTIME MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RENALPRO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVORX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 139 139
2020 157 157
2021 158 158
2022 148 148
2023 175 175
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 149 149
Inflation Problem 113 113
Deflation Problem 97 97
Adverse Event Without Identified Device or Use Problem 89 89
Fluid/Blood Leak 80 80
Leak/Splash 56 56
Material Puncture/Hole 45 45
Burst Container or Vessel 43 43
Failure to Deflate 41 41
Break 35 35
Entrapment of Device 27 27
Difficult to Remove 16 16
Difficult to Open or Close 11 11
Fracture 10 10
Improper or Incorrect Procedure or Method 7 7
Material Deformation 7 7
Physical Resistance/Sticking 7 7
Material Integrity Problem 6 6
Failure to Advance 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 6 6
Flaked 5 5
Obstruction of Flow 5 5
Material Perforation 5 5
Gas/Air Leak 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Defective Component 4 4
Contamination 4 4
Positioning Failure 4 4
Off-Label Use 3 3
Use of Device Problem 3 3
Unintended Deflation 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Damaged by Another Device 3 3
Difficult to Advance 3 3
Device Dislodged or Dislocated 2 2
Material Twisted/Bent 2 2
Device Contaminated During Manufacture or Shipping 2 2
No Apparent Adverse Event 2 2
Positioning Problem 2 2
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Eject 2 2
Structural Problem 1 1
Insufficient Flow or Under Infusion 1 1
Material Separation 1 1
Device Slipped 1 1
Stretched 1 1
Failure to Unfold or Unwrap 1 1
Display or Visual Feedback Problem 1 1
Partial Blockage 1 1
Collapse 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Fragmentation 1 1
Failure to Fold 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Air/Gas in Device 1 1
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1
No Flow 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 477 477
No Known Impact Or Consequence To Patient 108 108
No Consequences Or Impact To Patient 82 82
Vascular Dissection 20 20
No Patient Involvement 18 18
Rupture 18 18
Insufficient Information 18 18
Intracranial Hemorrhage 17 17
Thrombus 17 17
Thrombosis/Thrombus 14 14
Perforation of Vessels 13 13
Death 11 11
Obstruction/Occlusion 11 11
Hemorrhage/Bleeding 9 9
Stroke/CVA 8 8
Paresis 8 8
Ischemia 7 7
Neurological Deficit/Dysfunction 7 7
Foreign Body In Patient 7 7
Unspecified Nervous System Problem 6 6
Ruptured Aneurysm 4 4
Embolism/Embolus 4 4
Thromboembolism 4 4
Ischemia Stroke 4 4
Vasoconstriction 4 4
Pulmonary Embolism 4 4
Aneurysm 3 3
Hemorrhage, Subarachnoid 3 3
Laceration(s) 3 3
Muscle Weakness 3 3
Dysphasia 3 3
Iatrogenic Source 3 3
Vascular System (Circulation), Impaired 3 3
Blood Loss 3 3
Hemorrhagic Stroke 3 3
Hydrocephalus 3 3
Foreign Body Embolism 3 3
Unintended Radiation Exposure 2 2
Swelling/ Edema 2 2
Cerebral Edema 2 2
Nervous System Injury 2 2
No Information 2 2
No Code Available 2 2
Cancer 2 2
Pericardial Effusion 2 2
Pseudoaneurysm 2 2
Ascites 2 2
Cardiac Perforation 2 2
Necrosis 2 2
Blurred Vision 2 2
Loss of Vision 2 2
Great Vessel Perforation 2 2
Hemorrhage, Cerebral 2 2
Extravasation 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Headache 2 2
Hematoma 2 2
Infarction, Cerebral 2 2
Embolus 1 1
Arrhythmia 1 1
Cardiac Arrest 1 1
Syncope 1 1
Failure of Implant 1 1
Dizziness 1 1
Perforation 1 1
Transient Ischemic Attack 1 1
Intimal Dissection 1 1
Pain 1 1
Paralysis 1 1
Nausea 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Heart Failure 1 1
Respiratory Failure 1 1
Coma 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Device Embedded In Tissue or Plaque 1 1
Respiratory Arrest 1 1
Renal Impairment 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Sep-03-2019
2 Prytime Medical Devices, Inc. II Dec-23-2020
3 Spectranetics Corporation II Jun-01-2020
4 W. L. Gore & Associates Inc. II Aug-25-2021
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