BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

    MDR report key: 23951802 · Received January 2, 2026

    Report

    Report Number
    3015053858-2026-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 7, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000270
    PMA / PMN Number
    K203365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED FAILURES OF DETACHED CATHETER COMPONENT AND INABILITY TO REMOVE THE CATHETER WERE CONFIRMED. THE CATHETER WAS RETURNED WITH THE DISTAL PORTION OF THE DEVICE DETACHED AND MISSING. THE DETACHMENT OCCURRED PROXIMAL TO THE PROXIMAL MARKER BAND. PER THE REPORTED INFORMATION, IT WAS NOTED THAT THE CATHETER BECAME STUCK, AND DETACHMENT OCCURRED WHEN FORCE WAS USED TO TRY TO REMOVE THE DEVICE. PER THE IFU, IT IS NOTED: "DO NOT USE EXCESSIVE FORCE/TORQUE WHEN USING THIS DEVICE AS THIS COULD RESULT IN DAMAGE TO THE DEVICE COMPONENTS AND PATIENT INJURY." THE CAUSE OF THE DEVICE BECOMING STUCK COULD NOT BE DEFINITIVELY 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.

    Additional Manufacturer Narrative · 0

    SECTION H4 DEVICE MANUFACTURE DATE HAS BEEN CORRECTED TO 07/01/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT LESIONS IN BOTH ILIAC ARTERIES. THE SURGEON USED A 7.0MM M5+ CATHETER TO PERFORM IVL ON BOTH ILIAC ARTERIES VIA AN UP-AND-OVER APPROACH OVER A BOSTON SCIENTIFIC 0.014" THRUWAY WIRE, DELIVERING A TOTAL OF 170 PULSES ACROSS BOTH ILIACS (LEFT EXTERNAL AND COMMON, AND RIGHT COMMON). FOLLOWING DEFLATION OF THE BALLOON, THE IVL CATHETER WAS ATTEMPTED TO BE REMOVED AND BECAME STUCK. THE SURGEON APPLIED INCREASED TRACTION AND NEARLY ALL OF THE DEVICE WAS RETRIEVED, BUT THE BALLOON PORTION REMAINED INSIDE THE PATIENT, EVIDENCED BY THE BALLOON MARKERS. MULTIPLE ATTEMPTS TO SNARE AND RETRIEVE THE RETAINED PORTION USING TWO EN SNARE DEVICES WERE UNSUCCESSFUL. MULTIPLE VIABAHN STENTS WERE PLACED IN THE AORTA AND BILATERAL ILIACS, FOLLOWED BY BALLOON ANGIOPLASTY TO TREAT THE DISEASE AND PIN THE RETAINED PORTION OF THE BALLOON AGAINST THE VESSEL WALL. THERE WAS NO REPORT OF ANY PATIENT HARM THAT OCCURRED. THE PATIENT DID WELL, STAYED OVERNIGHT, AND WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11816 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 82343220 00195451000270

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| O| H 0.014" THRUWAY WIRE - BOSTON SCIENTIFIC.| 2X EN SNARE - MERIT MEDICAL SYSTEMS, INC.| STENTS - VIABAHN.