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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 139 139
Inflation Problem 110 110
Deflation Problem 94 94
Adverse Event Without Identified Device or Use Problem 86 86
Fluid/Blood Leak 80 80
Leak/Splash 52 52
Material Puncture/Hole 43 43
Burst Container or Vessel 41 41
Failure to Deflate 39 39
Break 33 33
Entrapment of Device 25 25
Difficult to Remove 15 15
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
Failure to Advance 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 6 6
Flaked 5 5
Material Perforation 5 5
Obstruction of Flow 5 5
Material Integrity Problem 5 5
Gas/Air Leak 4 4
Manufacturing, Packaging or Shipping Problem 4 4
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
Contamination 3 3
Off-Label Use 3 3
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Positioning Failure 2 2
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
Failure to Eject 2 2
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
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
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
Structural Problem 1 1
Defective Component 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 443 443
No Known Impact Or Consequence To Patient 108 108
No Consequences Or Impact To Patient 82 82
Vascular Dissection 19 19
No Patient Involvement 18 18
Rupture 18 18
Insufficient Information 18 18
Thrombus 17 17
Intracranial Hemorrhage 16 16
Perforation of Vessels 13 13
Thrombosis/Thrombus 13 13
Death 11 11
Obstruction/Occlusion 10 10
Hemorrhage/Bleeding 9 9
Paresis 8 8
Ischemia 7 7
Neurological Deficit/Dysfunction 7 7
Stroke/CVA 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
Vasoconstriction 4 4
Pulmonary Embolism 4 4
Aneurysm 3 3
Hemorrhage, Subarachnoid 3 3
Laceration(s) 3 3
Dysphasia 3 3
Iatrogenic Source 3 3
Vascular System (Circulation), Impaired 3 3
Blood Loss 3 3
Hemorrhagic Stroke 3 3
Ischemia 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
Pseudoaneurysm 2 2
Ascites 2 2
Cardiac Perforation 2 2
Muscle Weakness 2 2
Necrosis 2 2
Blurred Vision 2 2
Loss of Vision 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
Great Vessel Perforation 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
Pericardial Effusion 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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