BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER

    MDR report key: 23857994 · Received December 19, 2025

    Report

    Report Number
    3015053858-2025-00156
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 19, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000607
    PMA / PMN Number
    200039/S015
    Adverse Event
    Yes
    Product Problem
    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. BASED ON THE REPORTED INFORMATION, THE CAUSE OF THE BALLOON RUPTURE AND SUBSEQUENT PERFORATION COULD NOT BE DETERMINED. 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 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. IT WAS REPORTED THAT THE BALLOON RUPTURED AFTER FOUR (4) PULSES WHICH WAS OBSERVED UNDER FLUOROSCOPY AND CONTRAST STAINING. THE BALLOON WAS DEFLATED FOLLOWED BY ANGIOGRAPHY WHICH CONFIRMED A VESSEL PERFORATION. IT WAS NOTED THAT BALLOON TAMPONADE WAS APPLIED FOR SEVERAL MINUTES BUT BLEEDING PERSISTED, SO A DRUG ELUTING STENT (DES) WAS IMPLANTED AND A COVERED STENT PLACED INSIDE IT TO SEAL THE PERFORATION. THE PATIENT REQUIRED ADMISSION TO THE INTENSIVE CARE UNIT (ICU) HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED ON POST PROCEDURE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627747 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2AIVL3012 13A250715A 00195451000607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| H| R COVERED STENT - UNKNOWN MANUFACTURER| DRUG ELUTING STENT - UNKNOWN MANUFACTURER| INTRAVASCULAR ULTRASOUND - UNKNOWN MANUFACTURER