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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device balloon aortic valvuloplasty
Regulation Description Balloon aortic valvuloplasty catheter.
Definition A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Product CodeOZT
Regulation Number 870.1255
Device Class 2


Premarket Reviews
ManufacturerDecision
DISA MEDINOTEC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TORAY INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 18 18
2022 33 33
2023 47 47
2024 38 38
2025 34 34
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 50
Material Rupture 44 44
Leak/Splash 18 18
Difficult to Remove 16 16
Inflation Problem 11 11
Break 10 10
Deflation Problem 9 9
Detachment of Device or Device Component 8 8
Insufficient Information 7 7
Physical Resistance/Sticking 5 5
Packaging Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Retraction Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Entrapment of Device 3 3
Material Deformation 3 3
Air/Gas in Device 3 3
Perivalvular Leak 2 2
Fracture 2 2
Material Separation 2 2
Material Perforation 2 2
Patient-Device Incompatibility 2 2
Material Puncture/Hole 2 2
Output Problem 2 2
Burst Container or Vessel 2 2
Device-Device Incompatibility 2 2
Failure to Fold 1 1
Difficult to Insert 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Problem 1 1
Unintended Deflation 1 1
Difficult or Delayed Positioning 1 1
Unintended Movement 1 1
Difficult to Advance 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1
Malposition of Device 1 1
Migration 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Failure to Advance 1 1
Device Dislodged or Dislocated 1 1
Flushing Problem 1 1
Device Slipped 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Rupture 16 16
Aortic Valve Insufficiency/ Regurgitation 12 12
Low Blood Pressure/ Hypotension 12 12
Insufficient Information 12 12
Heart Block 11 11
Pericardial Effusion 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Foreign Body In Patient 5 5
Stroke/CVA 5 5
Hemorrhage/Bleeding 4 4
Cardiac Arrest 4 4
Perforation 4 4
Cardiac Perforation 4 4
Mitral Valve Insufficiency/ Regurgitation 4 4
Vascular Dissection 3 3
Cardiac Tamponade 3 3
Obstruction/Occlusion 3 3
Ventricular Fibrillation 3 3
Great Vessel Perforation 2 2
Tachycardia 2 2
Laceration(s) 2 2
Calcium Deposits/Calcification 2 2
Arrhythmia 2 2
Unspecified Tissue Injury 2 2
Cardiovascular Insufficiency 1 1
Valvular Insufficiency/ Regurgitation 1 1
Hemorrhagic Stroke 1 1
Unspecified Vascular Problem 1 1
Asystole 1 1
Low Cardiac Output 1 1
Device Embedded In Tissue or Plaque 1 1
Cusp Tear 1 1
Bradycardia 1 1
High Blood Pressure/ Hypertension 1 1
Hematoma 1 1
Dizziness 1 1
Perforation of Vessels 1 1

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