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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary carotid catheter for embolic capture
Definition This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
Product CodeNTE
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GARDIA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 158 158
2019 233 233
2020 238 238
2021 327 327
2022 326 326
2023 324 324

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 738 738
Difficult to Remove 196 196
Material Separation 159 159
Detachment of Device or Device Component 121 121
Retraction Problem 99 99
Improper or Incorrect Procedure or Method 88 88
Break 82 82
Difficult to Insert 75 75
Difficult to Advance 69 69
Deformation Due to Compressive Stress 55 55
Material Split, Cut or Torn 45 45
Stretched 38 38
Entrapment of Device 37 37
Activation Failure 36 36
Migration 32 32
Material Deformation 32 32
Off-Label Use 29 29
Fracture 28 28
Material Integrity Problem 27 27
Failure to Advance 25 25
Material Twisted/Bent 22 22
Device Damaged by Another Device 21 21
Deflation Problem 17 17
Difficult or Delayed Positioning 14 14
Unraveled Material 14 14
Burst Container or Vessel 13 13
Use of Device Problem 11 11
Contamination /Decontamination Problem 11 11
Product Quality Problem 8 8
Device Difficult to Setup or Prepare 8 8
Peeled/Delaminated 8 8
Inflation Problem 7 7
Defective Component 7 7
Device Dislodged or Dislocated 7 7
Activation, Positioning or Separation Problem 7 7
Physical Resistance/Sticking 6 6
Device Contamination with Chemical or Other Material 6 6
Positioning Problem 6 6
Leak/Splash 6 6
Detachment Of Device Component 6 6
Kinked 5 5
Material Too Soft/Flexible 5 5
Premature Activation 4 4
Device-Device Incompatibility 4 4
Physical Resistance 4 4
Defective Device 3 3
Component Missing 3 3
Difficult or Delayed Activation 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Compatibility Problem 3 3
Migration or Expulsion of Device 3 3
Unsealed Device Packaging 3 3
Material Frayed 3 3
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 2 2
Positioning Failure 2 2
Difficult To Position 2 2
Infusion or Flow Problem 2 2
Device Operates Differently Than Expected 2 2
Torn Material 2 2
Unintended Movement 2 2
Patient-Device Incompatibility 2 2
Malposition of Device 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Material Rupture 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Physical Property Issue 1 1
Difficult to Open or Close 1 1
Unintended System Motion 1 1
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Disconnection 1 1
Bent 1 1
Partial Blockage 1 1
Device Expiration Issue 1 1
Unintended Ejection 1 1
Fluid/Blood Leak 1 1
Difficult to Flush 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Vascular Dissection 446 446
No Clinical Signs, Symptoms or Conditions 389 389
No Consequences Or Impact To Patient 261 261
Stroke/CVA 124 124
Patient Problem/Medical Problem 114 114
Ischemia Stroke 77 77
Brain Injury 53 53
No Patient Involvement 39 39
Transient Ischemic Attack 34 34
Insufficient Information 34 34
Foreign Body In Patient 32 32
Embolism/Embolus 29 29
Myocardial Infarction 28 28
Thrombosis/Thrombus 24 24
Embolism 22 22
Obstruction/Occlusion 20 20
Hematoma 17 17
Perforation 16 16
Thrombosis 16 16
Unspecified Tissue Injury 16 16
Device Embedded In Tissue or Plaque 15 15
Occlusion 15 15
Hemorrhage/Bleeding 14 14
Low Blood Pressure/ Hypotension 14 14
Intimal Dissection 13 13
Bradycardia 13 13
Injury 13 13
Pseudoaneurysm 13 13
No Known Impact Or Consequence To Patient 13 13
Thrombus 11 11
Infarction, Cerebral 10 10
Intracranial Hemorrhage 10 10
Reocclusion 9 9
Vasoconstriction 8 8
Perforation of Vessels 8 8
Pain 7 7
Death 7 7
Restenosis 7 7
Extravasation 6 6
Weakness 6 6
Renal Failure 5 5
Blood Loss 5 5
Numbness 5 5
Nerve Damage 5 5
Vessel Or Plaque, Device Embedded In 5 5
Ischemia 5 5
Hemorrhage, Cerebral 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hemorrhagic Stroke 4 4
Paralysis 4 4
Paresis 4 4
Fistula 4 4
Cardiac Arrest 4 4
Stenosis 4 4
Thromboembolism 4 4
Dysphasia 3 3
Pulmonary Embolism 3 3
Convulsion/Seizure 3 3
No Code Available 3 3
No Information 2 2
Unspecified Nervous System Problem 2 2
Swelling/ Edema 2 2
Aneurysm 2 2
Arrhythmia 2 2
Muscle Weakness 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Respiratory Failure 2 2
Cognitive Changes 1 1
Coma 1 1
Loss of consciousness 1 1
Seizures 1 1
Loss of Range of Motion 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Dizziness 1 1
Convulsion, Tonic 1 1
Regurgitation 1 1
Failure of Implant 1 1
Hemorrhage, Intraventricular 1 1
Nausea 1 1
Atrial Fibrillation 1 1
Myocardial Contusion 1 1
Calcium Deposits/Calcification 1 1
Headache 1 1
Embolus 1 1
Chest Pain 1 1
Respiratory Arrest 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Cerebral Hyperperfusion Syndrome 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiovascular Systems Inc I Dec-21-2021
2 Cordis US Corp I May-11-2023
3 Medtronic Inc II Nov-17-2023
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