BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOREFLEX NC SCORING PTCA CATHETER

    MDR report key: 18344171 · Received December 18, 2023

    Report

    Report Number
    18344171
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    October 24, 2023
    Report Date
    October 25, 2023
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SCOREFLEX BALLOON INSERTED INTO LEFT MAIN CORONARY ARTERY EXTENDING TO LEFT ANTERIOR DESCENDING ARTERY. BALLOON BROKE WHILE ON DELIVERY WIRE. SURGEON WAS ABLE TO BE REMOVE INTACT WITHOUT AID OF ASSISTIVE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889198 SCOREFLEX NC SCORING PTCA CATHETER CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 625-104-1U 3620802307

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Male