BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19264742 · Received May 7, 2024

    Report

    Report Number
    3015053858-2024-00043
    Event Type
    Injury
    Date Received
    May 7, 2024
    Report Date
    May 7, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 EMBOLIZATION COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. 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 BEING DISTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION OCCURRED IN TWO SEPARATE EVENTS WHERE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED IN THE PROCEDURE. THERE WAS NO IVL CATHETER MALFUNCTION REPORTED. THIS REPORT IS FOR ONE OF THE TWO REPORTED EVENTS (REFERENCE MDR (B)(4) FOR THE OTHER CATHETER). THERE ARE NO ADDITIONAL DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670062 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other