BEUDAMED
    FDA Adverse Event Summary report: N

    SHOCKWAVE

    MDR report key: 14756361 · Received June 17, 2022

    Report

    Report Number
    MW5110395
    Date Received
    June 17, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 15, 2022
    Manufacturer
    SHOCKWAVE MEDICAL INC.
    Product Code
    QMG
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BALLOON ON SHOCKWAVE DEVICE DID NOT INFLATE FULLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775121 SHOCKWAVE SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM QMG SHOCKWAVE MEDICAL INC. A220125M

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male