BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 15204263 · Received August 10, 2022

    Report

    Report Number
    3015053858-2022-00053
    Event Type
    Injury
    Date Received
    August 10, 2022
    Report Date
    July 21, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS PUBLICATION WAS NOT RETURNED THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, TWO PATIENTS DURING THE STUDY EXPERIENCED CORONARY ARTERY BYPASS GRAFT (CABG). THIS REPORT IS TO CAPTURE ONE OF THE TWO PATIENTS THAT EXPERIENCE CABG. DUE TO INSUFFICIENT INFORMATION/ DETAILS REGARDING THE EVENT, THE CAUSE IS NOT ESTABLISHED - INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED CABG WITHIN THE PUBLICATION. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Description of Event or Problem · 0

    FROM PUBLICATION ITSELF (IRISH JOURNAL OF MEDICAL SCIENCE (1971 -). HTTPS://DOI.ORG/10.1007/S11845-022-03077-9): A RETROSPECTIVE SINGLE-CENTER STUDY WAS CONDUCTED OF PATIENTS TREATED WITH CORONARY IVL BETWEEN JANUARY AND OCTOBER 2020. A TOTAL OF 62 SHOCKWAVE¿ BALLOONS WERE USED IN 47 PATIENTS. PROCEDURAL OUTCOMES (REFERENCE TABLE 3 OF PUBLICATION): WITHIN THE PUBLICATION, IT WAS NOTED THAT TWO PATIENTS EXPERIENCED CORONARY ARTERY BYPASS GRAFT (CABG) DURING THE STUDY AT THE ST. JAMES HOSPITAL. THIS REPORT IS TO COVER ONE OF THE TWO PATIENT(S) THAT EXPERIENCED CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382600 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER NTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other