BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 24760741 · Received April 1, 2026

    Report

    Report Number
    3015053858-2026-00031
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 1, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000034
    PMA / PMN Number
    P200039/S008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PHYSICIAN REPORTED ENCOUNTERING SIGNIFICANT RESISTANCE DURING ADVANCEMENT AND APPLIED FORCE TO ADVANCE THE CATHETER, WHICH RESULTED IN CATHETER DAMAGE. HOWEVER, THE DAMAGE CANNOT BE CONFIRMED WITHOUT A REVIEW OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE C2+ CORONARY IVL CATHETER WAS USED TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK ARTERY WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE STATE "SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER IS INDICATED FOR LITHOTRIPSY-ENABLED, LOW-PRESSURE BALLOON DILATATION OF SEVERELY CALCIFIED, STENOTIC DE NOVO CORONARY ARTERIES PRIOR TO STENTING." SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK ARTERY. THE PHYSICIAN WAS AWARE OF THE OFF-LABEL USE AS THE SHOCKWAVE C2+ IVL CATHETER IS INDICATED FOR LITHOTRIPSY-ENABLED, LOW-PRESSURE BALLOON DILATATION OF SEVERELY CALCIFIED, STENOTIC DE NOVO CORONARY ARTERIES PRIOR TO STENTING. IT WAS REPORTED THAT THE CATHETER WAS DAMAGED DURING USE, RESULTING IN A SEPARATION OF THE CATHETER WHEN THE PHYSICIAN ATTEMPTED TO PULL IT OUT. THE BROKEN SHAFT REMAINED INSIDE THE 5 FR INTRODUCER SHEATH. IT WAS NOT DETERMINED WHETHER THE CATHETER WAS KINKED PRIOR TO USE. THE PHYSICIAN BELIEVES THE CATHETER MOST LIKELY DAMAGED DURING ADVANCEMENT, AS HE REPORTED SIGNIFICANT RESISTANCE WHILE ADVANCING THE CATHETER AND NOTED DIFFICULTY POSITIONING THE BALLOON AT THE INTENDED LOCATION. THE BREAK WAS ESTIMATED TO HAVE OCCURRED IN THE MID TO DISTAL SHAFT, WITH THE CATHETER STILL INSIDE THE INTRODUCER SHEATH AT THE POINT OF FAILURE. THE BROKEN CATHETER WAS SNARED AND REMOVED, RESULTING IN ADDITIONAL PROCEDURE TIME, ALTHOUGH IT DID NOT IMPACT OR CHANGE THE PROCEDURE PERFORMED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625071 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL4012 02A250404B 00195451000034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 5 FR SHEATH - UNKNOWN MANUFACTURER| SNARE - UNKNOWN MANUFACTURER