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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 178 178
2024 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 150 150
Inflation Problem 115 115
Deflation Problem 97 97
Adverse Event Without Identified Device or Use Problem 91 91
Fluid/Blood Leak 80 80
Leak/Splash 60 60
Material Puncture/Hole 47 47
Burst Container or Vessel 44 44
Failure to Deflate 41 41
Break 36 36
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
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Damaged by Another Device 3 3
Difficult to Advance 3 3
Unintended Deflation 3 3
Failure to Eject 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
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 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
Device Handling 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
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
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Air/Gas in Device 1 1
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 486 486
No Known Impact Or Consequence To Patient 108 108
No Consequences Or Impact To Patient 82 82
Vascular Dissection 20 20
Rupture 19 19
No Patient Involvement 18 18
Intracranial Hemorrhage 18 18
Insufficient Information 18 18
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 6 6
Embolism/Embolus 5 5
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
Cognitive Changes 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
Confusion/ Disorientation 1 1
Heart Failure 1 1
Respiratory Failure 1 1
Hypovolemia 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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