BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE

    MDR report key: 14854096 · Received June 28, 2022

    Report

    Report Number
    MW5110562
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    April 4, 2022
    Report Date
    June 24, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE THE SHOCKWAVE BALLOON WAS BEING REMOVED FROM PT AND THE DELIVERY SYSTEM AND BALLOON BROKE OF IN THE LAD. COULD NOT BE REMOVED RESULTING IN ADDITIONAL SURGERY. CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472987 SHOCKWAVE SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM QMG SHOCKWAVE MEDICAL, INC. A220125E

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H