BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21978001 · Received May 7, 2025

    Report

    Report Number
    3015053838-2025-00066
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 20, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000140
    PMA / PMN Number
    K180958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RECEIVED AT SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION HAS NOT BEEN PERFORMED. EVALUATION OF THE SUBJECT DEVICE IS ANTICIPATED BUT HAS NOT YET BEGUN. AFTER THE DEVICE IS RECEIVED AND INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 PACKAGING ISSUE COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    SHOCKWAVE MEDICAL RECEIVED A REPORT INVOLVING A SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. IT WAS REPORTED THAT DURING A PROCEDURE IN THE OPERATING ROOM (OR), A CATHETER WAS REMOVED FROM ITS SEALED PACKAGING. UPON OPENING THE CARTON, IT WAS DISCOVERED THAT THE CATHETER POUCH HAD LABELS MARKED "NOT FOR HUMAN USE" AND "TEST SAMPLE," AND THE CATHETER HAD A "REJECTED" LABEL ATTACHED. IT WAS REPORTED THAT BLOOD WAS OBSERVED ON THE PACKAGING WHICH WAS LATER CONFIRMED TO BE FROM THE PHYSICIAN. ADDITIONALLY, IT WAS NOTED THAT THE CATHETER DID NOT COME INTO CONTACT WITH THE PATIENT, AND THE IVL TREATMENT WAS NOT USED TO COMPLETE THE PROCEDURE. THE METHOD USED TO COMPLETE THE PROCEDURE REMAINS UNKNOWN. SHOCKWAVE MEDICAL WILL CONTINUE TO FOLLOW UP ON THE EXPECTED RETURN OF THE DEVICE TO AID IN THE INVESTIGATION EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140071 SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5IVL4560 01A240723A 00195451000140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other