BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 25119597 · Received May 7, 2026

    Report

    Report Number
    3015053858-2026-00041
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 7, 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. THERE WAS NO IVL MALFUNCTION REPORTED. A SAFETY REVIEW COMPLETED BY SHOCKWAVE MEDICAL DETERMINED THAT, DUE TO LIMITED CLINICAL INFORMATION, THE RELATIONSHIP BETWEEN THE REPORTED MYOCARDIAL INFARCTION (MI) AND THE DEVICE OR PROCEDURE CANNOT BE DEFINITIVELY ASSESSED. IN THE ABSENCE OF SUFFICIENT EVENT DETAILS, THE MI IS CONSERVATIVELY CLASSIFIED AS POSSIBLY RELATED. 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 VIA A NON-SHOCKWAVE SPONSORED JAPAN POST MARKET CLINICAL STUDY (MARBLE J), A PROSPECTIVE, MULTICENTER STUDY EVALUATING THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY SYSTEM IN CALCIFIED CORONARY ARTERY LESIONS. ACCORDING TO INFORMATION RECEIVED, A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION WITH THE USE OF THE SHOCKWAVE C2 CORONARY IVL CATHETER DURING A MARBLE J STUDY PROCEDURE. THE REPORTED EVENT DID NOT SPECIFY WHETHER THE EVENT OCCURRED BEFORE, DURING OR FOLLOWING THE IVL PROCEDURE. FURTHER CLINICAL DETAILS WERE NOT PROVIDED. THERE WAS NO IVL MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514228 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1