BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19726410 · Received July 11, 2024

    Report

    Report Number
    3015053858-2024-00068
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 11, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. THE CAUSE OF THE TACHYCARDIA COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT'S HEART RATE INCREASED TO 120 TO 130 BPM AND THE PATIENT BECAME TACHYCARDIAC. THE REPORTED TACHYCARDIA STOPPED SHORTLY AFTER THE IVL TREATMENT WAS STOPPED AND THE PATIENTS' SINUS RHYTHM WAS RESTORED. THE PHYSICIAN DID NOT CONTINUE THE LITHOTRIPSY TREATMENT. NO FURTHER PATIENT HARM AND NO IVL DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315905 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL5060 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other