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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Definition Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Product CodeOMZ
Regulation Number 870.1250
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2021 5 5
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6 6
Inflation Problem 3 3
Leak/Splash 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Break 1 1
Burst Container or Vessel 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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