BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE II PRO

    MDR report key: 10045839 · Received May 11, 2020

    Report

    Report Number
    3003775186-2020-01643
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LOX
    PMA / PMN Number
    K173680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING ADVANCEMENT THROUGH A STENT TO TREAT A LESION, THE SAPPHIRE II PRO BALLOON TORE AND THE TIP CAME OFF THE END. THE PROCEDURE WAS CONTINUED SUCCESSFULLY WITH A SECOND SAPPHIRE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509145 SAPPHIRE II PRO PTCA BALLOON LOX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4251161909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention