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TPLC
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show TPLC since
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Device
valvulotome
Product Code
MGZ
Regulation Number
870.4885
Device Class
2
Premarket Reviews
Manufacturer
Decision
LEMAITRE VASCULAR
SUBSTANTIALLY EQUIVALENT
1
1. K190267
EZE SIT Valvulotome
LIMFLOW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
6
6
2021
2
2
2022
13
13
2023
23
23
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Retraction Problem
20
20
Difficult to Open or Close
19
19
Adverse Event Without Identified Device or Use Problem
9
9
Failure to Align
5
5
Break
2
2
Material Deformation
2
2
Material Twisted/Bent
2
2
Connection Problem
2
2
Device Markings/Labelling Problem
1
1
Flare or Flash
1
1
Positioning Problem
1
1
Sharp Edges
1
1
Fluid/Blood Leak
1
1
Difficult to Flush
1
1
Leak/Splash
1
1
Failure to Cut
1
1
Material Separation
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
23
23
No Known Impact Or Consequence To Patient
13
13
Perforation of Vessels
12
12
Laceration(s)
5
5
Insufficient Information
3
3
No Consequences Or Impact To Patient
3
3
No Patient Involvement
3
3
Foreign Body In Patient
1
1
No Information
1
1
Injury
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
LeMaitre Vascular, Inc.
II
Aug-28-2023
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