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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 191 191

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 799 799
Material Separation 176 176
Difficult to Remove 170 170
Detachment of Device or Device Component 112 112
Retraction Problem 109 109
Break 98 98
Difficult to Insert 86 86
Improper or Incorrect Procedure or Method 80 80
Difficult to Advance 65 65
Deformation Due to Compressive Stress 64 64
Material Split, Cut or Torn 47 47
Stretched 43 43
Entrapment of Device 42 42
Activation Failure 41 41
Material Deformation 35 35
Migration 32 32
Material Twisted/Bent 29 29
Material Integrity Problem 28 28
Fracture 28 28
Failure to Advance 26 26
Off-Label Use 22 22
Device Damaged by Another Device 18 18
Difficult or Delayed Positioning 14 14
Deflation Problem 13 13
Use of Device Problem 13 13
Unraveled Material 12 12
Device Difficult to Setup or Prepare 11 11
Contamination /Decontamination Problem 11 11
Device Dislodged or Dislocated 10 10
Burst Container or Vessel 10 10
Peeled/Delaminated 8 8
Device Contamination with Chemical or Other Material 8 8
Activation, Positioning or Separation Problem 7 7
Material Too Soft/Flexible 7 7
Inflation Problem 7 7
Product Quality Problem 7 7
Defective Component 6 6
Leak/Splash 6 6
Physical Resistance/Sticking 6 6
Positioning Problem 6 6
Premature Activation 5 5
Component Missing 4 4
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Defective Device 3 3
Compatibility Problem 3 3
Infusion or Flow Problem 3 3
Device-Device Incompatibility 3 3
Insufficient Information 2 2
Unintended Movement 2 2
Appropriate Term/Code Not Available 1 1
Device Fell 1 1
Difficult to Open or Close 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Suction Problem 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Unintended System Motion 1 1
Unsealed Device Packaging 1 1
Partial Blockage 1 1
Disconnection 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 497 497
No Clinical Signs, Symptoms or Conditions 491 491
No Consequences Or Impact To Patient 176 176
Stroke/CVA 129 129
Ischemia Stroke 102 102
Patient Problem/Medical Problem 85 85
Brain Injury 48 48
Embolism/Embolus 38 38
Insufficient Information 36 36
Transient Ischemic Attack 33 33
No Patient Involvement 32 32
Foreign Body In Patient 30 30
Thrombosis/Thrombus 28 28
Myocardial Infarction 28 28
Obstruction/Occlusion 25 25
Embolism 20 20
Hematoma 19 19
Muscle Weakness 18 18
Unspecified Tissue Injury 17 17
Perforation 16 16
Thrombosis 13 13
Injury 13 13
Pseudoaneurysm 13 13
Low Blood Pressure/ Hypotension 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
Vasoconstriction 8 8
Perforation of Vessels 8 8
Thrombus 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
High Blood Pressure/ Hypertension 3 3
Swelling/ Edema 3 3
Convulsion/Seizure 3 3
Speech Disorder 2 2
Unspecified Nervous System Problem 2 2
Hemorrhage, Cerebral 2 2
Unspecified Infection 2 2
Pulmonary Embolism 2 2
Aneurysm 2 2
Arrhythmia 2 2
Respiratory Failure 2 2
No Information 2 2
No Code Available 2 2
Loss of Vision 2 2
Visual Disturbances 1 1
Seizures 1 1
Loss of Range of Motion 1 1
Dizziness 1 1
Convulsion, Tonic 1 1
Regurgitation 1 1
Cerebral Hyperperfusion Syndrome 1 1
Cognitive Changes 1 1
Coma 1 1
Loss of consciousness 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
Failure of Implant 1 1
Nausea 1 1
Aphonia 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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