BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

    MDR report key: 23318833 · Received October 16, 2025

    Report

    Report Number
    3015053858-2025-00119
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 16, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000256
    PMA / PMN Number
    K203365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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 CAUSE OF THE DETACHMENT COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO PATIENT HARM REPORTED. 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 M5+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. THE IVL PROCEDURE WAS COMPLETED, ALTHOUGH THE EXACT NUMBER OF PULSES DELIVERED IS UNKNOWN. AFTER DEFLATING THE BALLOON, ATTEMPTS WERE MADE TO REMOVE THE IVL CATHETER THROUGH THE SHEATH; HOWEVER, THE BALLOON COULD NOT BE REMOVED DESPITE MULTIPLE EFFORTS TO PULL NEGATIVE AGAINST THE BALLOON. ULTIMATELY, THE SHAFT OF THE IVL CATHETER DETACHED, LEAVING THE CLEAR BALLOON INSIDE THE SHEATH. IT WAS DECIDED TO REMOVE THE SHEATH WITH THE BALLOON STILL INSIDE AND TO RE-SHEATH THE PATIENT WITH A NEW SHEATH. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252306 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL7060 82297876 00195451000256

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other| R SHEATH - UNKNOWN MANUFACTURER