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TPLC
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Device
temporary coronary saphenous vein bypass graft for embolic protection
Regulation Description
Percutaneous catheter.
Product Code
NFA
Regulation Number
870.1250
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
20
20
2021
25
25
2022
23
23
2023
22
22
2024
55
55
2025
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
85
85
Difficult to Remove
61
61
Adverse Event Without Identified Device or Use Problem
22
22
Difficult or Delayed Positioning
22
22
Difficult to Advance
11
11
Break
6
6
Entrapment of Device
5
5
Failure to Advance
4
4
Mechanical Problem
3
3
Device Difficult to Setup or Prepare
3
3
Detachment of Device or Device Component
3
3
Fracture
3
3
Activation, Positioning or Separation Problem
2
2
Device-Device Incompatibility
2
2
Defective Device
2
2
Retraction Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Material Split, Cut or Torn
1
1
Migration or Expulsion of Device
1
1
Device Markings/Labelling Problem
1
1
Unsealed Device Packaging
1
1
Contamination
1
1
Device Damaged by Another Device
1
1
Material Separation
1
1
Activation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
143
143
No Consequences Or Impact To Patient
17
17
Foreign Body In Patient
4
4
Vasoconstriction
3
3
Insufficient Information
3
3
Obstruction/Occlusion
2
2
Stenosis
2
2
Device Embedded In Tissue or Plaque
2
2
High Blood Pressure/ Hypertension
1
1
Vascular Dissection
1
1
Perforation
1
1
Embolism/Embolus
1
1
Cardiac Arrest
1
1
No Known Impact Or Consequence To Patient
1
1
Paralysis
1
1
Coma
1
1
Myocardial Infarction
1
1
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