BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE NC PLUS

    MDR report key: 8711368 · Received June 19, 2019

    Report

    Report Number
    8711368
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RAPID EXCHANGE BALLOON SHAFT HYPERTUBE BROKEN MID SHAFT. MANUFACTURER RESPONSE FOR CORONARY PTA BALLOON, SAPPHIRE NC PLUS (PER SITE REPORTER). INVESTIGATION UPON RECEIPT OF MALFUNCTIONING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506109 SAPPHIRE NC PLUS CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 235-123-2U 3417381809

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA