BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 24989206 · Received April 24, 2026

    Report

    Report Number
    3015053858-2026-00038
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    December 2, 2025
    Report Date
    April 24, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE MYOCARDIAL INFARCTION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. BASED ON ADDITION INFORMATION RECEIVED FROM THE SITE, THE MYOCARDIAL INFARCTION OCCURRED IN THE RCA OF A DIFFERENT BRANCH, NOT IN THE VESSEL WHERE IVL THERAPY WAS PERFORMED. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED TO SHOCKWAVE MEDICAL THROUGH THE MARBLE-J STUDY. A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) IN A DIFFERENT BRANCH OF THE RCA, NOT IN THE VESSEL TREATED WITH IVL, ON THE DAY FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS INTENDED AND THE PATIENT WAS DISCHARGED. ACCORDING TO THE PHYSICIAN, THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE IVL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583607 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening