BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 14429774 · Received May 18, 2022

    Report

    Report Number
    14429774
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 9, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CATHETER FOR THE SHOCKWAVE WAS INSIDE THE PATIENT'S BODY AND SHOCKS WERE BEING APPLIED TO THE BALLOON. THE FIRST ROUND WENT AS EXPECTED. WHILE ADMINISTERING THE SECOND ROUND OF SHOCKS, THE DOCTOR NOTED THAT HE COULD SEE ELECTRICAL SPARKS INSIDE THE CLEAR END OF THE CATHETER. THE SHOCKWAVE WAS IMMEDIATELY STOPPED AT THAT TIME AND THE CATHETER WAS REMOVED FROM THE BODY. NO OBVIOUS SIGNS NOTED TO THE CATHETER ITSELF. THE PATIENT DID NOT APPEAR TO HAVE ANY INJURY OR AWARENESS OF MALFUNCTION. THE CATHETER WAS RETAINED TO BE SENT TO THE MANUFACTURER AND DEVICE WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851287 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM QMG SHOCKWAVE MEDICAL, INC. 3.5 X 12MM A211113C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male