BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 23835066 · Received December 17, 2025

    Report

    Report Number
    3015053858-2025-00155
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 17, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000034
    PMA / PMN Number
    P200039/S008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED FAILURE WAS CONFIRMED. THE CATHETER WAS RETURNED BROKEN AND SEPARATED INTO TWO PIECES. BASED ON REVIEW OF THE RETURNED DEVICES, IT WAS CONFIRMED THAT ALL COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. PER THE REPORTED INFORMATION, THE DEVICE WAS UNABLE TO ADVANCE THROUGH A PRE-EXISTING STENT WHICH IS CONSIDERED OFF-LABEL USE BASED ON THE INSTRUCTIONS FOR USE. THE IVL CATHETER IS INTENDED TO BE USED IN DE NOVO LESIONS. IT IS LIKELY THAT THE BALLOON GOT STUCK UPON ATTEMPTS TO REMOVE THROUGH THE PRE-EXISTING STENT RESULTING IN ADDITIONAL FORCE AND SUBSEQUENT DETACHMENT OF THE DEVICE. 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

    IT WAS REPORTED THAT A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A PATIENT'S AORTA. THE IVL CATHETER WAS PREPARED SUCCESSFULLY. WHEN THE IVL BALLOON WAS ADVANCED TOWARD THE AORTIC BI-FEMORAL GRAFT, IT WOULD NOT ADVANCE THROUGH A PRE-EXISTING STENT. THE LESION WAS LOCATED AT THE PROXIMAL STENT SEGMENT WITHIN THE GRAFT ANASTOMOSIS. THE BALLOON BECAME STUCK AT THE DISTAL STENT SEGMENT AND COULD NOT BE ADVANCED TO THE LESION. DURING ATTEMPTED REMOVAL, THE IVL BALLOON AND CATHETER BROKE APART FROM THE SHAFT AT APPROXIMATELY ONE-THIRD OF THE DISTAL LENGTH. THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVE THE ENTIRE DISTAL CATHETER AND BALLOON INTACT. IT WAS REPORTED THAT THERE WAS NO BALLOON RUPTURE OR LOSS OF PRESSURE BEFORE THE DEVICE BECAME DIFFICULT TO REMOVE, AND THE BALLOON HAD BEEN FULLY DEFLATED PRIOR TO THE REMOVAL ATTEMPT. THERE WAS NO REPORT OF ANY PATIENT HARM THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193549 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 01A241111B 00195451000034

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other| R SNARE - UNKNOWN MANUFACTURER