BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE II PRO

    MDR report key: 11810741 · Received May 12, 2021

    Report

    Report Number
    3014148220-2021-01711
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE SAPPHIRE BALLOON FRACTURED DURING USE; THE TIP OF THE BALLOON WAS ABANDONED IN VIVO SINCE IT COULD NOT BE REMOVED FROM THE DIAGONAL BRANCH. THERE WAS LITTLE TO NO FLOW IN THE VESSEL PAST THE TIP FRAGMENT. A PERFORATION ALSO OCCURRED, BUT IT IS UNKNOWN IF OR HOW THE BALLOON MAY HAVE CONTRIBUTED TO THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710056 SAPPHIRE II PRO SAPPHIRE II PRO LOX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4203582002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O