BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 23550376 · Received November 13, 2025

    Report

    Report Number
    3015053858-2025-00137
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    July 10, 2025
    Report Date
    November 13, 2025
    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. A REVIEW BY SHOCKWAVE MEDICAL SAFETY DETERMINED THAT THERE IS INSUFFICIENT INFORMATION TO DETERMINE RELATABILITY TO THE DEVICE OR THE PROCEDURE THEREFORE THIS EVENT IS CONSERVATIVELY ASSESSED AS HAVING A POSSIBLE RELATIONSHIP TO THE DEVICE AND PROCEDURE. 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

    AN EVENT WAS REPORTED VIA THE MARBLE J STUDY (NON-SHOCKWAVE SPONSORED STUDY) THAT A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE AND A MYOCARDIAL INFARCTION (MI) OCCURRED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION RELATED TO THE IVL CATHETER, AND THERE IS INSUFFICIENT INFORMATION TO ASSESS THE RELATIONSHIP TO THE IVL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983803 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening