BEUDAMED
    FDA Adverse Event Other Summary report: N

    B. BRAUN INTERVENTIONAL SYSTEMS ZMED BALLOON

    MDR report key: 19607444 · Received June 24, 2024

    Report

    Report Number
    MW5156558
    Event Type
    Other
    Date Received
    June 24, 2024
    Report Date
    June 20, 2024
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC. / NUMED, INC.
    Product Code
    OZT
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ZMED BALLOON RUPTURED UPON INFLATION DURING PULMONIC VALVULOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626075 B. BRAUN INTERVENTIONAL SYSTEMS ZMED BALLOON BALLOON AORTIC VALVULOPLASTY OZT B. BRAUN INTERVENTIONAL SYSTEMS, INC. / NUMED, INC. PDA663 ZZ-15739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown