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TPLC
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show TPLC since
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2019
2020
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2024
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Device
guide, wire, catheter, neurovasculature
Product Code
MOF
Regulation Number
870.1330
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K220934
RADIFOCUS Torque Device
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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