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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
Premarket Reviews
Manufacturer
Decision
CAPTURE VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
PENUMBRA, INC.
SE - WITH LIMITATIONS
1
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
30
30
2021
81
81
2022
16
16
2023
25
25
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
75
75
Break
71
71
Material Deformation
50
50
Fracture
32
32
Failure to Advance
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
Leak/Splash
1
1
Difficult to Advance
1
1
Positioning Problem
1
1
Stretched
1
1
Improper or Incorrect Procedure or Method
1
1
Difficult to Remove
1
1
Material Twisted/Bent
1
1
Migration
1
1
Suction Problem
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
154
154
No Consequences Or Impact To Patient
46
46
Foreign Body In Patient
9
9
Encephalopathy
1
1
Death
1
1
Stroke/CVA
1
1
No Known Impact Or Consequence To Patient
1
1
Insufficient Information
1
1
Perforation of Vessels
1
1
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