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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 3
INTERVENTION TECH, INC. ; DBA CORVENTION
  SUBSTANTIALLY EQUIVALENT 1
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 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 51 51
Material Rupture 50 50
Difficult to Remove 25 25
Leak/Splash 20 20
Inflation Problem 13 13
Deflation Problem 12 12
Improper or Incorrect Procedure or Method 10 10
Break 10 10
Detachment of Device or Device Component 9 9
Insufficient Device Problem Information 7 7
Material Deformation 6 6
Retraction Problem 5 5
Packaging Problem 5 5
Device-Device Incompatibility 4 4
Entrapment of Device 4 4
Physical Resistance/Sticking 4 4
Air/Gas in Device 4 4
Device Contamination with Chemical or Other Material 3 3
Failure to Advance 2 2
Perivalvular Leak 2 2
Fracture 2 2
Material Perforation 2 2
Patient Device Interaction Problem 2 2
Patient-Device Incompatibility 2 2
Peeled/Delaminated 2 2
Output Problem 2 2
Burst Container or Vessel 2 2
Unraveled Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Insert 1 1
Device Damaged by Another Device 1 1
Failure to Fold 1 1
Difficult or Delayed Positioning 1 1
Positioning Problem 1 1
Unintended Deflation 1 1
Unintended Movement 1 1
Difficult to Advance 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Puncture/Hole 1 1
Migration 1 1
Component Misassembled 1 1
Malposition of Device 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 103 103
Rupture 17 17
Low Blood Pressure/ Hypotension 13 13
Insufficient Information 13 13
Aortic Valve Insufficiency/ Regurgitation 12 12
Heart Block 11 11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 8 8
Pericardial Effusion 7 7
Stroke/CVA 5 5
Foreign Body In Patient 5 5
Perforation 4 4
Cardiac Arrest 4 4
Cardiac Perforation 4 4
Mitral Valve Insufficiency/ Regurgitation 4 4
Hemorrhage/Blood Loss/Bleeding 4 4
Vascular Dissection 3 3
Obstruction/Occlusion 3 3
Cardiac Tamponade 3 3
Ventricular Fibrillation 3 3
Hemodynamic instability 2 2
Great Vessel Perforation 2 2
Unspecified Tissue Injury 2 2
Perforation of Vessels 2 2
Tachycardia 2 2
Calcium Deposits/Calcification 2 2
Asystole 2 2
Laceration(s) 2 2
Arrhythmia 2 2
Retroperitoneal Hemorrhage 1 1
Bradycardia 1 1
Hemorrhagic Stroke 1 1
Cusp Tear 1 1
Low Cardiac Output 1 1
Valvular Insufficiency/ Regurgitation 1 1
Hematoma 1 1
Coronary obstruction/occlusion 1 1
Dizziness 1 1
Cardiovascular Dysfunction/Insufficiency 1 1
Unspecified Vascular Problem 1 1
Intraoperative Cardiac Valve Injury 1 1
Hypovolemic Shock 1 1
Aortic dissection 1 1
Device Embedded In Tissue or Plaque 1 1
High Blood Pressure/ Hypertension 1 1

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