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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
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 233 233
2020 238 238
2021 327 327
2022 326 326
2023 354 354
2024 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 761 761
Difficult to Remove 163 163
Material Separation 159 159
Detachment of Device or Device Component 110 110
Retraction Problem 97 97
Break 92 92
Difficult to Insert 82 82
Improper or Incorrect Procedure or Method 73 73
Difficult to Advance 63 63
Deformation Due to Compressive Stress 62 62
Material Split, Cut or Torn 45 45
Activation Failure 40 40
Stretched 37 37
Entrapment of Device 36 36
Material Deformation 33 33
Migration 29 29
Material Integrity Problem 28 28
Fracture 27 27
Failure to Advance 25 25
Material Twisted/Bent 24 24
Off-Label Use 22 22
Device Damaged by Another Device 18 18
Use of Device Problem 13 13
Deflation Problem 13 13
Difficult or Delayed Positioning 12 12
Unraveled Material 11 11
Contamination /Decontamination Problem 11 11
Burst Container or Vessel 10 10
Device Difficult to Setup or Prepare 9 9
Peeled/Delaminated 8 8
Inflation Problem 7 7
Product Quality Problem 7 7
Activation, Positioning or Separation Problem 7 7
Material Too Soft/Flexible 6 6
Physical Resistance/Sticking 6 6
Positioning Problem 6 6
Device Dislodged or Dislocated 6 6
Device Contamination with Chemical or Other Material 6 6
Leak/Splash 6 6
Premature Activation 5 5
Defective Component 5 5
Component Missing 4 4
Defective Device 3 3
Compatibility Problem 3 3
Infusion or Flow Problem 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device-Device Incompatibility 3 3
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 2 2
Unintended Movement 2 2
Difficult to Open or Close 1 1
Connection Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1
Patient-Device Incompatibility 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Partial Blockage 1 1
Mechanical Problem 1 1
Unintended System Motion 1 1
Unsealed Device Packaging 1 1
Disconnection 1 1
Material Frayed 1 1
Fluid/Blood Leak 1 1
Difficult to Flush 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Vascular Dissection 470 470
No Clinical Signs, Symptoms or Conditions 440 440
No Consequences Or Impact To Patient 176 176
Stroke/CVA 125 125
Ischemia Stroke 93 93
Patient Problem/Medical Problem 85 85
Brain Injury 48 48
Insufficient Information 36 36
Embolism/Embolus 33 33
Transient Ischemic Attack 33 33
No Patient Involvement 32 32
Myocardial Infarction 28 28
Foreign Body In Patient 28 28
Thrombosis/Thrombus 26 26
Obstruction/Occlusion 21 21
Embolism 20 20
Hematoma 19 19
Unspecified Tissue Injury 16 16
Perforation 15 15
Muscle Weakness 14 14
Low Blood Pressure/ Hypotension 13 13
Thrombosis 13 13
Injury 13 13
Pseudoaneurysm 13 13
Hemorrhage/Bleeding 12 12
Occlusion 12 12
Bradycardia 12 12
Intracranial Hemorrhage 10 10
No Known Impact Or Consequence To Patient 10 10
Intimal Dissection 8 8
Infarction, Cerebral 8 8
Device Embedded In Tissue or Plaque 8 8
Perforation of Vessels 8 8
Thrombus 7 7
Vasoconstriction 7 7
Dysphasia 7 7
Death 7 7
Reocclusion 7 7
Restenosis 7 7
Pain 6 6
Extravasation 6 6
Weakness 6 6
Renal Failure 5 5
Numbness 5 5
Blood Loss 5 5
Nerve Damage 5 5
Ischemia 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
Thromboembolism 4 4
Stenosis 3 3
Vessel Or Plaque, Device Embedded In 3 3
Cardiac Arrest 3 3
Convulsion/Seizure 3 3
Swelling/ Edema 3 3
Unspecified Nervous System Problem 2 2
Pulmonary Embolism 2 2
Aneurysm 2 2
Arrhythmia 2 2
Unspecified Infection 2 2
High Blood Pressure/ Hypertension 2 2
Hemorrhage, Cerebral 2 2
Respiratory Failure 2 2
No Information 2 2
No Code Available 2 2
Cerebral Hyperperfusion Syndrome 1 1
Cognitive Changes 1 1
Coma 1 1
Loss of consciousness 1 1
Seizures 1 1
Loss of Range of Motion 1 1
Dizziness 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Convulsion, Tonic 1 1
Regurgitation 1 1
Failure of Implant 1 1
Nausea 1 1
Atrial Fibrillation 1 1
Myocardial Contusion 1 1
Calcium Deposits/Calcification 1 1
Chest Pain 1 1
Headache 1 1
Embolus 1 1
Aphonia 1 1
Speech Disorder 1 1
Respiratory Arrest 1 1
Cramp(s) /Muscle Spasm(s) 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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