BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER SHOCKWAVE C2 IVL

    MDR report key: 13142171 · Received December 30, 2021

    Report

    Report Number
    MW5106412
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 27, 2021
    Report Date
    December 29, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD NEEDED TO USE A SHOCKWAVE BALLOON ON THIS PARTICULAR PATIENT. BALLOON WAS INSERTED INTO THE PATIENT, BUT THE BALLOON FAILED AFTER 4 PULSES (SHOULD HAVE PULSED 10 TIMES). BLOOD WAS NOTED TO HAVE COME BACK INTO THE INTELLI-SYSTEM. BALLOON REMOVED FROM PATIENT. VENDOR AWARE OF ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021505 CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER SHOCKWAVE C2 IVL SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM QMG SHOCKWAVE MEDICAL, INC. C21VL3012 A210903A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown