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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 181 181
2024 211 211

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 187 187
Inflation Problem 122 122
Adverse Event Without Identified Device or Use Problem 107 107
Deflation Problem 105 105
Fluid/Blood Leak 84 84
Leak/Splash 74 74
Burst Container or Vessel 49 49
Material Puncture/Hole 48 48
Failure to Deflate 47 47
Break 36 36
Entrapment of Device 27 27
Difficult to Remove 17 17
Patient Device Interaction Problem 13 13
Difficult to Open or Close 11 11
Fracture 11 11
Material Deformation 11 11
Improper or Incorrect Procedure or Method 8 8
Physical Resistance/Sticking 8 8
Mechanical Problem 6 6
Failure to Advance 6 6
Detachment of Device or Device Component 6 6
Contamination 6 6
Flaked 5 5
Material Integrity Problem 5 5
Material Perforation 5 5
Gas/Air Leak 5 5
Obstruction of Flow 5 5
Positioning Failure 5 5
Difficult to Advance 4 4
Defective Component 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Appropriate Term/Code Not Available 3 3
Device Dislodged or Dislocated 3 3
Failure to Unfold or Unwrap 3 3
Device Damaged by Another Device 3 3
Use of Device Problem 3 3
Difficult to Insert 3 3
Off-Label Use 3 3
Insufficient Information 3 3
Unintended Deflation 3 3
Device Contaminated During Manufacture or Shipping 2 2
Failure to Eject 2 2
No Apparent Adverse Event 2 2
Tear, Rip or Hole in Device Packaging 2 2
Positioning Problem 2 2
Material Twisted/Bent 2 2
Component Missing 2 2
Improper Flow or Infusion 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 560 560
No Known Impact Or Consequence To Patient 108 108
No Consequences Or Impact To Patient 82 82
Vascular Dissection 32 32
Insufficient Information 25 25
Intracranial Hemorrhage 23 23
Rupture 22 22
Thrombosis/Thrombus 19 19
Hemorrhage/Bleeding 18 18
Perforation of Vessels 18 18
No Patient Involvement 18 18
Thrombus 17 17
Obstruction/Occlusion 13 13
Death 11 11
Ruptured Aneurysm 10 10
Paresis 9 9
Unspecified Nervous System Problem 9 9
Stroke/CVA 8 8
Thromboembolism 8 8
Ischemia 8 8
Foreign Body In Patient 7 7
Neurological Deficit/Dysfunction 7 7
Ischemia Stroke 6 6
Hematoma 6 6
Aneurysm 5 5
Embolism/Embolus 5 5
Pulmonary Embolism 4 4
Vasoconstriction 4 4
Fistula 3 3
Nervous System Injury 3 3
Hemorrhage, Subarachnoid 3 3
Vascular System (Circulation), Impaired 3 3
Hydrocephalus 3 3
Laceration(s) 3 3
Foreign Body Embolism 3 3
Iatrogenic Source 3 3
Dysphasia 3 3
Hemorrhagic Stroke 3 3
Blood Loss 3 3
Cognitive Changes 3 3
Muscle Weakness 3 3
Unintended Radiation Exposure 2 2
Cerebral Edema 2 2
Infarction, Cerebral 2 2
Status Epilepticus 2 2
Cancer 2 2
No Code Available 2 2
Ascites 2 2
Loss of Vision 2 2
Headache 2 2

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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