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TPLC
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Device
coronary mechanical thrombectomy with aspiration
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Product Code
QEX
Regulation Number
870.5150
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
30
30
2021
81
81
2022
16
16
2023
25
25
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
71
71
Break
71
71
Material Deformation
50
50
Failure to Advance
19
19
Fracture
19
19
Suction Failure
10
10
Material Puncture/Hole
9
9
Adverse Event Without Identified Device or Use Problem
3
3
Connection Problem
2
2
Suction Problem
1
1
Migration
1
1
Improper or Incorrect Procedure or Method
1
1
Material Twisted/Bent
1
1
Difficult to Remove
1
1
Leak/Splash
1
1
Stretched
1
1
Fluid/Blood Leak
1
1
Positioning Problem
1
1
Difficult to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
140
140
No Consequences Or Impact To Patient
46
46
Foreign Body In Patient
8
8
Stroke/CVA
1
1
Death
1
1
No Known Impact Or Consequence To Patient
1
1
Perforation of Vessels
1
1
Insufficient Information
1
1
Encephalopathy
1
1
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