Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
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
2018 1 1
2019 4 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 4 4
Inflation Problem 3 3
Detachment of Device or Device Component 2 2
Retraction Problem 2 2
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 1 1
Leak/Splash 1 1
Difficult to Remove 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 5 5
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1

-
-