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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
Regulation Description Percutaneous catheter.
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
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
2020 238 238
2021 327 327
2022 326 326
2023 354 354
2024 398 398
2025 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 849 849
Material Separation 206 206
Difficult to Remove 186 186
Retraction Problem 120 120
Detachment of Device or Device Component 113 113
Break 109 109
Improper or Incorrect Procedure or Method 104 104
Difficult to Insert 101 101
Difficult to Advance 83 83
Deformation Due to Compressive Stress 79 79
Material Split, Cut or Torn 55 55
Stretched 52 52
Entrapment of Device 45 45
Activation Failure 42 42
Material Twisted/Bent 42 42
Failure to Advance 35 35
Migration 33 33
Device Dislodged or Dislocated 31 31
Material Deformation 30 30
Material Integrity Problem 28 28
Fracture 25 25
Device Damaged by Another Device 19 19
Difficult or Delayed Positioning 19 19
Use of Device Problem 17 17
Unraveled Material 13 13
Device Difficult to Setup or Prepare 13 13
Off-Label Use 13 13
Contamination /Decontamination Problem 11 11
Material Too Soft/Flexible 10 10
Burst Container or Vessel 9 9
Deflation Problem 8 8
Peeled/Delaminated 8 8
Device Contamination with Chemical or Other Material 8 8
Defective Component 7 7
Inflation Problem 7 7
Leak/Splash 7 7
Activation, Positioning or Separation Problem 6 6
Positioning Problem 5 5
Device Markings/Labelling Problem 5 5
Physical Resistance/Sticking 5 5
Device-Device Incompatibility 5 5
Premature Activation 5 5
Device Misassembled During Manufacturing /Shipping 4 4
Product Quality Problem 3 3
Component Missing 3 3
Defective Device 3 3
Material Frayed 3 3
Infusion or Flow Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 673 673
Vascular Dissection 550 550
Stroke/CVA 149 149
Ischemia Stroke 133 133
No Consequences Or Impact To Patient 82 82
Embolism/Embolus 56 56
Muscle Weakness 46 46
Insufficient Information 41 41
Foreign Body In Patient 40 40
Brain Injury 39 39
Thrombosis/Thrombus 38 38
Obstruction/Occlusion 35 35
Patient Problem/Medical Problem 31 31
Myocardial Infarction 29 29
Transient Ischemic Attack 28 28
Perforation 20 20
Hematoma 20 20
Unspecified Tissue Injury 17 17
No Patient Involvement 16 16
Low Blood Pressure/ Hypotension 14 14
Bradycardia 13 13
Vasoconstriction 13 13
Dysphasia 13 13
Device Embedded In Tissue or Plaque 12 12
Hemorrhage/Bleeding 12 12
Intracranial Hemorrhage 11 11
Pseudoaneurysm 11 11
Perforation of Vessels 10 10
Restenosis 9 9
Embolism 9 9
Extravasation 7 7
Injury 7 7
Pain 6 6
Occlusion 5 5
Intimal Dissection 5 5
Renal Failure 5 5
Blood Loss 5 5
Hemorrhagic Stroke 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Paralysis 5 5
Nerve Damage 5 5
Reocclusion 4 4
Paresis 4 4
Numbness 4 4
Ischemia 4 4
Death 4 4
High Blood Pressure/ Hypertension 4 4
Thrombosis 3 3
No Known Impact Or Consequence To Patient 3 3
Respiratory Failure 3 3

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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