BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21715646 · Received March 27, 2025

    Report

    Report Number
    3015053858-2025-00051
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 27, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000287
    PMA / PMN Number
    K203365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT AVAILABLE FOR RETURN TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE EXACT CAUSE OF THE PERFORATION AND HEMATOMA COULD NOT BE DETERMINED; HOWEVER, THE PHYSICIAN STATED THAT BALLOON INFLATION AGAINST A CALCIFIED LESION OR SHEATH ADVANCEMENT MAY HAVE BEEN CONTRIBUTING FACTORS. THERE WAS NO IVL MALFUNCTION 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+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT WITH SEVERE CALCIFIED ILIAC ARTERY DISEASE. THE IVL CATHETER 300 SUCCESSFULLY DELIVERED 300 PULSES. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT COMMON ILIAC ARTERY PERFORATED, LEADING TO A SIGNIFICANT DROP IN ARTERIAL BLOOD PRESSURE AND NECESSITATING INTUBATION. THE PHYSICIAN DEPLOYED COVERED STENTS EMERGENTLY TO ADDRESS THE PERFORATION. THE EXACT CAUSE OF THE PERFORATION IS UNCERTAIN, WITH POTENTIAL FACTORS INCLUDING BALLOON INFLATION AGAINST A CALCIFIED LESION OR SHEATH ADVANCEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS INTUBATED BUT OTHERWISE STABLE. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE AND DISCHARGED THE FOLLOWING DAY WITH NO ADDITIONAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432656 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL8060 82318814 00195451000287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0.014" INTERVENTIONAL WIRE| 0.018" GLIDE ADVANTAGE WIRE| 8 FR DESTINATION SHEATH| EVERCROSS BALLOON 5.0MM