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TPLC
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Device
occluder, catheter tip
Regulation Description
Catheter tip occluder.
Product Code
DQT
Regulation Number
870.1370
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
11
11
2021
2
2
2022
5
5
2023
4
4
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
7
7
Fracture
4
4
Activation, Positioning or Separation Problem
3
3
Protective Measures Problem
3
3
Material Fragmentation
2
2
Failure to Deflate
2
2
Material Frayed
1
1
Leak/Splash
1
1
Break
1
1
Mechanical Problem
1
1
Unsealed Device Packaging
1
1
Material Integrity Problem
1
1
Unraveled Material
1
1
Packaging Problem
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
Device Embedded In Tissue or Plaque
6
6
Laceration(s)
3
3
No Consequences Or Impact To Patient
3
3
Perforation
2
2
Exposure to Body Fluids
2
2
Death
1
1
Vascular Dissection
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
LeMaitre Vascular, Inc.
II
May-12-2025
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