BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 20413966 · Received October 9, 2024

    Report

    Report Number
    3015053858-2024-00117
    Event Type
    Injury
    Date Received
    October 9, 2024
    Report Date
    October 9, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THE JOURNAL PUBLICATION WAS NOT AVAILABLE FOR RETURN TO SHOCKWAVE MEDICAL INC. THE DEVICE LOT NUMBER OR SIZE WAS NOT REPORTED, THEREFORE, ADDITIONAL INFORMATION COULD NOT BE OBTAINED. THE CAUSE OF THE REPORTED PERFORATION COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE IN THE JOURNAL. THERE WAS NO REPORT OF ANY IVL DEVICE MALFUNCTION. A REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION AVAILABLE. 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 ARTICLE RELATED TO INTRAVASCULAR LITHOTRIPSY (IVL) IN CHRONIC TOTAL OCCLUSIONS (CTO) PERCUTANEOUS CORONARY INTERVENTIONS REPORTING PERFORATIONS AND LIFE-THREATENING ARRHYTHMIAS ENTITLED "INTRAVASCULAR LITHOTRIPSY IN HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION: PROCEDURAL AND ONE-YEAR CLINICAL OUTCOMES" WAS PUBLISHED IN THE CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS JOURNAL BY WILEY PERIODICALS LLC (DOI: 10.1002/CCD.31207). THERE IS NO AVAILABLE INFORMATION ON PRODUCT TYPE, PATIENTS' HEALTH HISTORY, PROCEDURE/EVENT DATE, OR CAUSAL DEVICE RELATIONSHIP. THIS IS REPORT 1 OF 3 ASSOCIATED TO THIS PUBLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260197 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVLXXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other