Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
dilator, catheter
Product Code
GCC
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
3
3
2021
2
2
2022
2
2
2023
3
3
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
11
11
Break
3
3
Burst Container or Vessel
1
1
Off-Label Use
1
1
Device Markings/Labelling Problem
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Material Rupture
1
1
Tear, Rip or Hole in Device Packaging
1
1
Fracture
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Tamponade
5
5
Insufficient Information
3
3
No Known Impact Or Consequence To Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Sepsis
1
1
No Clinical Signs, Symptoms or Conditions
1
1
No Information
1
1
Tricuspid Valve Insufficiency/ Regurgitation
1
1
Perforation
1
1
Post Operative Wound Infection
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Laceration(s)
1
1
No Consequences Or Impact To Patient
1
1
Hemothorax
1
1
Low Blood Pressure/ Hypotension
1
1
-
-