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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valvulotome
Product CodeMGZ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
LEMAITRE VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
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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