BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO VISIONS PV .014P

    MDR report key: 19549016 · Received June 14, 2024

    Report

    Report Number
    MW5156304
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 12, 2024
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEFT HEART CATH DURING IVUS (INTRAVASCULAR ULTRASOUND) IMAGING, THE TIP OF THE IVUS CATHETER HAD DISCONNECTED FROM THE CATHETER, REMAINING IN THE BODY. MD RETRIEVED THE FOREIGN BODY, AND THE CASE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687604 VOLCANO VISIONS PV .014P CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS ULTRASOUND LLC 03031

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female