BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17826173 · Received September 27, 2023

    Report

    Report Number
    3015053858-2023-00056
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 8, 2023
    Report Date
    September 8, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000089
    PMA / PMN Number
    P200039
    Product Problem
    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 RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. VISUAL INSPECTION OF THE EMITTERS SHOWED SIGNS OF WEAR, AN INDICATION THAT THEY HAVE BEEN FIRED. DURING THE INVESTIGATION, IT WAS NOTED THAT ONE HALF OF THE EMITTER OUTER BAND WAS DISLODGED FROM ITS LOCATION, AND IT COULD NOT BE LOCATED INSIDE THE BALLOON. THE OTHER HALF WAS FOUND LOCATED AT THE DISTAL BALLOON TIP. BASED ON THE INVESTIGATION OF THE DEVICE, THE REPORTED DEVICE FAILURE IS CONFIRMED. THE REPORTED BALLOON LOSS OF PRESSURE WAS ALSO CONFIRMED. THERE WAS A LONGITUDINAL TEAR STARTING FROM EMITTER 1, EXTENDING TO 9MM. THE LIKELY CAUSE OF THE BALLOON LOSS OF PRESSURE COULD BE ATTRIBUTED TO PATIENT CALCIUM A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASED FOR DISTRIBUTION. 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

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED TO TREAT A DE NOVO LESION IN THE CORONARY ARTERY. AFTER DELIVERING 30 PULSES, A BALLOON LOSS OF PRESSURE OCCURRED. POST IVL TREATMENT, INTRAVASCULAR ULTRASOUND (IVUS) WAS INITIATED TO VIEW THE LESION. AN IMAGE OF A FOREIGN PARTICLE WAS OBSERVED IN IVUS WHICH THE PHYSICIAN SUSPECTED IT TO BE AN IVL MATERIAL THAT BROKE OFF.. ANOTHER IVL WAS PREPPED AND USED TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. ANOTHER IVUS IMAGING WAS TAKEN AFTER THE USE OF THE SECOND DEVICE. IT WAS REPORTED THAT THE FOREIGN PARTICLE APPEARED TO BE ON A DIFFERENT SITE FROM THE FIRST IMAGE THAT WAS TAKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776364 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PRODUCT CODE: QMG (CORONARY) QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 11B230502A 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INTRAVASCULAR ULTRASOUND (IVUS) CATHETERS - UNK MF.