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TPLC
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Device
balloon aortic valvuloplasty
Definition
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Product Code
OZT
Regulation Number
870.1255
Device Class
2
Premarket Reviews
Manufacturer
Decision
DONGGUAN TT MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
1. K231814
ValvuloPro Valvuloplasty Balloon Catheter
TORAY INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
11
11
2021
18
18
2022
33
33
2023
48
48
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
37
37
Material Rupture
28
28
Leak/Splash
11
11
Difficult to Remove
9
9
Inflation Problem
9
9
Break
8
8
Insufficient Information
7
7
Detachment of Device or Device Component
6
6
Retraction Problem
6
6
Deflation Problem
4
4
Material Puncture/Hole
4
4
Physical Resistance/Sticking
4
4
Difficult to Insert
3
3
Failure to Fold
3
3
Improper or Incorrect Procedure or Method
3
3
Output Problem
2
2
Packaging Problem
2
2
Device-Device Incompatibility
2
2
Material Perforation
2
2
Fracture
2
2
Entrapment of Device
2
2
Burst Container or Vessel
2
2
Peeled/Delaminated
2
2
Perivalvular Leak
2
2
Material Split, Cut or Torn
2
2
Unintended Deflation
1
1
Air/Gas in Device
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Flushing Problem
1
1
Device Damaged Prior to Use
1
1
Defective Device
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Positioning Problem
1
1
Unintended Movement
1
1
Suction Problem
1
1
Migration
1
1
Component Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
39
39
Rupture
14
14
Heart Block
9
9
Aortic Valve Insufficiency/ Regurgitation
8
8
Insufficient Information
8
8
Low Blood Pressure/ Hypotension
8
8
No Consequences Or Impact To Patient
7
7
No Patient Involvement
5
5
Pericardial Effusion
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Cardiac Perforation
4
4
Perforation
4
4
Hemorrhage/Bleeding
4
4
Cardiac Tamponade
3
3
Obstruction/Occlusion
3
3
Vascular Dissection
2
2
Device Embedded In Tissue or Plaque
2
2
Foreign Body In Patient
2
2
Aortic Insufficiency
2
2
Calcium Deposits/Calcification
2
2
Stroke/CVA
2
2
Death
2
2
Embolism
2
2
Laceration(s)
2
2
Tachycardia
2
2
Ventricular Fibrillation
2
2
Mitral Valve Insufficiency/ Regurgitation
2
2
Unspecified Tissue Injury
2
2
Cardiovascular Insufficiency
1
1
Valvular Insufficiency/ Regurgitation
1
1
Great Vessel Perforation
1
1
Dizziness
1
1
Mitral Regurgitation
1
1
Myocardial Infarction
1
1
Hematoma
1
1
Cardiac Arrest
1
1
High Blood Pressure/ Hypertension
1
1
No Known Impact Or Consequence To Patient
1
1
Cusp Tear
1
1
Unspecified Vascular Problem
1
1
Asystole
1
1
Low Cardiac Output
1
1
Injury
1
1
Renal Failure
1
1
Intimal Dissection
1
1
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