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TPLC
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show TPLC since
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Device
occluder, catheter tip
Product Code
DQT
Regulation Number
870.1370
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
6
6
2016
2
2
2017
4
4
2018
12
12
2019
21
21
2020
11
11
2021
2
2
2022
5
5
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
15
15
Material Fragmentation
10
10
Fracture
10
10
Break
10
10
Detachment of Device or Device Component
8
8
Mechanical Problem
8
8
Material Integrity Problem
6
6
Device Or Device Fragments Location Unknown
4
4
Protective Measures Problem
3
3
Failure to Deflate
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Material Perforation
1
1
Material Separation
1
1
Retraction Problem
1
1
Leak/Splash
1
1
Material Frayed
1
1
Crack
1
1
Knotted
1
1
Unraveled Material
1
1
Fluid/Blood Leak
1
1
Burst Container or Vessel
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
34
34
Device Embedded In Tissue or Plaque
14
14
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
5
5
Laceration(s)
3
3
Death
2
2
Perforation
2
2
No Patient Involvement
2
2
Exposure to Body Fluids
2
2
Air Embolism
1
1
No Code Available
1
1
Vascular Dissection
1
1
Pericardial Effusion
1
1
Cardiac Arrest
1
1
Electro-Mechanical Dissociation
1
1
Cardiac Tamponade
1
1
Ventricular Fibrillation
1
1
Foreign Body In Patient
1
1
Insufficient Information
1
1
Perforation of Vessels
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Vascular
I
Nov-15-2013
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