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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device guide, wire, catheter, neurovasculature
Product CodeMOF
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTIRIA MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICRO VENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID-MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 11 11
2019 12 12
2020 18 18
2021 39 39
2022 92 92
2023 91 91
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 100 100
Fracture 86 86
Break 26 26
Adverse Event Without Identified Device or Use Problem 23 23
Detachment of Device or Device Component 20 20
Insufficient Information 8 8
Material Fragmentation 8 8
Material Split, Cut or Torn 4 4
Material Separation 3 3
Inaccurate Information 3 3
Stretched 2 2
Solder Joint Fracture 2 2
Malposition of Device 1 1
Material Deformation 1 1
Physical Resistance/Sticking 1 1
Appropriate Term/Code Not Available 1 1
Device Damaged Prior to Use 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
No Consequences Or Impact To Patient 21 21
Foreign Body In Patient 17 17
Intracranial Hemorrhage 12 12
Perforation of Vessels 12 12
Hemorrhage/Bleeding 4 4
Insufficient Information 4 4
Hypersensitivity/Allergic reaction 3 3
Muscle Weakness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
No Patient Involvement 2 2
No Code Available 1 1
Foreign Body Embolism 1 1
Vascular Dissection 1 1
Numbness 1 1
Obstruction/Occlusion 1 1
Nausea 1 1
Paralysis 1 1
Paresis 1 1
Increased Sensitivity 1 1
Vasoconstriction 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Weakness 1 1
Tingling 1 1
Dysphasia 1 1
Inflammation 1 1
Hemorrhage, Cerebral 1 1
Autoimmune Reaction 1 1
Stroke/CVA 1 1
Embolism 1 1
Headache 1 1

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