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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
2018 7 7
2019 19 19
2020 6 6
2021 2 2
2022 13 13
2023 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 23 23
Retraction Problem 18 18
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Align 5 5
Material Deformation 4 4
Material Twisted/Bent 2 2
Connection Problem 2 2
Break 2 2
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
Device Markings/Labelling Problem 1 1
Flare or Flash 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 15 15
Perforation of Vessels 13 13
Laceration(s) 6 6
No Information 4 4
Insufficient Information 3 3
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Injury 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Aug-28-2023
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