BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 16920463 · Received May 12, 2023

    Report

    Report Number
    3015053858-2023-00028
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 3, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, AFTER THE IVL BALLOON DELIVERED 5 PULSES, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) ON THE 2ND PULSE AS SEEN ON THE ELECTROCARDIOGRAM. THE EXACT CAUSE OF THE VF COULD NOT BE DEFINITIVELY DETERMINED. AFTER THE PATIENT WAS RESUSCITATED WITH THE USE OF DEFIBRILLATOR PADS, SINUS RHYTHM WAS RESTORED. THE INITIAL IVL BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A LESION IN THE CORONARY ARTERY DUE TO ST ELEVATION MYOCARDIAL INFARCTION (STEMI). AFTER THE SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON DELIVERED 5 PULSES, ELECTROCARDIOGRAM (ECG) SHOWED THAT ON THE 2ND PULSE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) ARREST. THE PATIENT SHOWED SYMPTOMS VIA THE ECG, BUT THE PATIENT WAS REPORTED TO BE UNWELL DUE TO STEMI. DEFIBRILLATOR PADS WERE PLACED ON THE PATIENT AND AFTER PROVIDING ONE SHOCK, THE PATIENT'S SINUS RHYTHM WAS RESTORED. ONCE RESTORED, THE PHYSICIAN USED THE SAME IVL CATHETER TO SUCCESSFULLY COMPLETE THE PCI. THE PATIENT HAD PROLONGED HOSPITALIZATION DUE TO THE PRIMARY PCI. THE PHYSICIAN HYPOTHESIZED THAT IT WAS THE SHOCK ON THE R ON T WAVE THAT THE IVL PULSE HAD OCCURRED BUT WERE NOT WORRIED AS THE VF IS A COMMON ACUTE PHASE OF STEMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309830 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVLXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O| R DEFRIBRILLATOR PADS - UNKNOWN MANUFACTURER