BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17366855 · Received July 20, 2023

    Report

    Report Number
    3015053858-2023-00047
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000096
    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 RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. THE REPORTED DEVICE SEPARATION WAS CONFIRMED HOWEVER, THE BALLOON LOSS OF PRESSURE WAS UNABLE TO BE CONFIRMED BECAUSE THE DISTAL PORTION OF THE DEVICE WAS NOT RETURNED. BASED ON THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT WHEN THE BALLOON WAS RETRACTED BACK TO THE PROXIMAL LESION, IT GOT ENTRAPPED BY CALCIUM. DURING MANIPULATIONS TO UNSTICK THE BALLOON, IT RUPTURED AND COULDN'T BE DISLODGED. THE IVL CATHETER SHAFT FRACTURED WHILE IT WAS BEING REMOVED PERCUTANEOUSLY FROM THE PATIENT WITH THE OTHER DEVICES. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). PRIOR TO THE START OF THE PCI, A NON-COMPLIANT (NC) BALLOON WAS USED TO PRE-DILATE THE LESION, HOWEVER, THE BALLOON RUPTURED. THE PHYSICIAN DECIDED TO USE A ROTOBLATOR TO REMOVE THE CALCIUM FROM THE TARGET VESSEL. FOLLOWING A SUCCESSFUL ROTOBLATOR PROCEDURE, THE PHYSICIAN ADVANCED THE SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER TO THE DISTAL LESION. THE BALLOON SUCCESSFULLY DELIVERED 30 PULSES AND THEN IT WAS RETRACTED BACK TO THE PROXIMAL LESION. HOWEVER, THE BALLOON BECAME ENTRAPPED BY CORONARY CALCIUM DESPITE SEVERAL ROUNDS OF THERAPY AT THE SITE. THE PHYSICIAN ATTEMPTED TO PULL BACK THE BALLOON, PULLED DOUBLE NEGATIVE AND ATTEMPTED TO WIRE AROUND WITHOUT SUCCESS. THE BALLOON WAS INFLATED, AND IT APPEARED TO HAVE DEFORMED AS VISUALLY OBSERVED VIA ANGIOGRAM AND IVUS IMAGING. THE PHYSICIAN CONTINUED TO MANIPULATE THE CATHETER TO REMOVE THE STUCK BALLOON AT WHICH THE BALLOON RUPTURED. THE PHYSICIAN INSERTED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON NEXT TO THE IVL BALLOON TO REMOVE IT, BUT THE IVL BALLOON COULDN'T BE DISLODGED FROM THE LEFT MAIN (LM). THE PHYSICIAN USED THE TRAPPING BALLOON TECHNIQUE BY INSERTING THE TRAPPING BALLOON CATHETER INSIDE THE GUIDE CATHETER TO WITHDRAW THE WHOLE SYSTEM AS A UNIT. CONTRAST WAS INJECTED AND IT SHOWED THAT TIMI1 AND TIMI2 FLOWS WERE OBSERVED. IT WAS REPORTED THAT THE IVL CATHETER SHAFT FRACTURED WHILE IT WAS BEING REMOVED PERCUTANEOUSLY AND THEN THE SURGEON HAD TO CUT IT LEAVING THE BALLOON ITSELF LODGED IN THE LM. THE PATIENT WAS TRANSFERRED TO SURGERY FOR A CORONARY ARTERY BYPASS TO REMOVE THE REMAINS OF THE IVL CATHETER FROM THE LM. THE PATIENT IS RECOVERING POST BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664919 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 A221004A 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization| R| L PTA BALLOON - UNKNOWN BRAND/MANUFACTURER| ROTOBLATOR - UNKNOWN MANUFACTURER| TRAPPING BALLOON CATHETER - UNKNOWN MANUFACTURER