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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

MDR Year MDR Reports MDR Events
2017 141 141
2018 158 158
2019 233 233
2020 238 238
2021 327 327
2022 209 209

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 574 574
Difficult to Remove 171 171
Material Separation 105 105
Detachment of Device or Device Component 92 92
Improper or Incorrect Procedure or Method 78 78
Retraction Problem 73 73
Break 63 63
Difficult to Insert 54 54
Difficult to Advance 46 46
Deformation Due to Compressive Stress 33 33
Material Split, Cut or Torn 32 32
Migration 29 29
Material Deformation 27 27
Entrapment of Device 27 27
Stretched 26 26
Off-Label Use 26 26
Fracture 26 26
Detachment Of Device Component 23 23
Deflation Problem 23 23
Failure to Advance 22 22
Device Damaged by Another Device 22 22
Activation Failure 21 21
Material Integrity Problem 20 20
Material Twisted/Bent 17 17
Migration or Expulsion of Device 15 15
Burst Container or Vessel 14 14
Unraveled Material 14 14
Kinked 13 13
Physical Resistance 9 9
Device Contamination with Chemical or Other Material 9 9
Contamination /Decontamination Problem 8 8
Use of Device Problem 8 8
Activation, Positioning or SeparationProblem 7 7
Defective Component 7 7
Leak/Splash 7 7
Peeled/Delaminated 6 6
Product Quality Problem 6 6
Physical Resistance/Sticking 6 6
Inflation Problem 6 6
Device Dislodged or Dislocated 6 6
Torn Material 6 6
Material Frayed 6 6
Positioning Problem 5 5
Difficult or Delayed Positioning 4 4
Premature Activation 4 4
Device Difficult to Setup or Prepare 4 4
Defective Device 4 4
Positioning Failure 4 4
Compatibility Problem 4 4
Device-Device Incompatibility 4 4
Device Misassembled During Manufacturing /Shipping 3 3
Unsealed Device Packaging 3 3
Device Operates Differently Than Expected 3 3
Patient Device Interaction Problem 3 3
Difficult To Position 3 3
Difficult or Delayed Activation 3 3
Device Markings/Labelling Problem 2 2
Component Missing 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Material Too Soft/Flexible 2 2
Infusion or Flow Problem 2 2
Patient-Device Incompatibility 2 2
Incomplete or Missing Packaging 1 1
Bent 1 1
Hole In Material 1 1
Device Handling Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Capture 1 1
Device Fell 1 1
Physical Property Issue 1 1
Appropriate Term/Code Not Available 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Device Expiration Issue 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1
Looping 1 1
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Difficult to Open or Close 1 1
Coiled 1 1
Connection Problem 1 1
Malposition of Device 1 1
Device Damaged Prior to Use 1 1
Disconnection 1 1
Occlusion Within Device 1 1
Unintended System Motion 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 321 321
Vascular Dissection 293 293
No Clinical Signs, Symptoms or Conditions 204 204
Patient Problem/Medical Problem 129 129
Stroke/CVA 124 124
Brain Injury 53 53
No Patient Involvement 45 45
Ischemia Stroke 38 38
Transient Ischemic Attack 33 33
Embolism 31 31
Foreign Body In Patient 27 27
Insufficient Information 24 24
Myocardial Infarction 22 22
Occlusion 21 21
Intimal Dissection 18 18
Thrombosis 18 18
Device Embedded In Tissue or Plaque 18 18
Embolism/Embolus 16 16
Hematoma 16 16
Death 15 15
No Known Impact Or Consequence To Patient 15 15
Injury 14 14
Thrombus 14 14
Thrombosis/Thrombus 14 14
Unspecified Tissue Injury 14 14
Perforation 13 13
Obstruction/Occlusion 13 13
Infarction, Cerebral 12 12
Hemorrhage/Bleeding 12 12
Low Blood Pressure/ Hypotension 12 12
Bradycardia 11 11
Pseudoaneurysm 11 11
Vasoconstriction 9 9
Reocclusion 9 9
Hemorrhage, Cerebral 8 8
Pain 6 6
Vessel Or Plaque, Device Embedded In 6 6
Weakness 6 6
Stenosis 5 5
Blood Loss 5 5
Perforation of Vessels 5 5
Intracranial Hemorrhage 5 5
Fistula 5 5
Aneurysm 4 4
Paresis 4 4
Thromboembolism 4 4
Restenosis 4 4
No Code Available 4 4
Coma 3 3
Renal Failure 3 3
Pulmonary Embolism 3 3
Cardiac Arrest 3 3
Paralysis 3 3
Nerve Damage 3 3
Unspecified Infection 3 3
Ischemia 3 3
Extravasation 2 2
High Blood Pressure/ Hypertension 2 2
Numbness 2 2
Dysphasia 2 2
Convulsion/Seizure 2 2
No Information 2 2
Hemorrhagic Stroke 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Nervous System Problem 1 1
Dizziness 1 1
Loss of consciousness 1 1
Cognitive Changes 1 1
Vascular System (Circulation), Impaired 1 1
Loss of Range of Motion 1 1
Seizures 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Convulsion, Tonic 1 1
Regurgitation 1 1
Embolus 1 1
Chest Pain 1 1
Ecchymosis 1 1
Myocardial Contusion 1 1
Calcium Deposits/Calcification 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Muscle Weakness 1 1
Neurological Deficit/Dysfunction 1 1
Headache 1 1
Failure of Implant 1 1
Hemorrhage, Intraventricular 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiovascular Systems Inc I Dec-21-2021
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