BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACROSSE NSE CORONARY DILATATION CATHETER

    MDR report key: 19803693 · Received July 23, 2024

    Report

    Report Number
    3007835716-2024-00234
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 14, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THE INVESTIGATION, THERE WERE NO ABNORMALITIES IN THE RETURNED PRODUCT. IT IS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY PATIENT LESION CONDITION, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE YOU AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE. ALTHOUGH THE PATIENT IS IN GOOD CONDITION AFTER OPERATION, WE ARE REPORTING THIS EVENT BECAUSE ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    THE BALLOON WAS USING FOR OPERATION BUT IT COULD NOT PASS THE LESION. THEN THE PATIENT'S HEART RATE DECREASED, THEREFORE DRUG ADMINISTERED FOR INTERVENTION. THE OPERATION WAS FINISHED WITHOUT ANY MORE OPERATION. THE PATIENT IS NOW IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472536 LACROSSE NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX GOODMAN CO., LTD. NS27513 NCG230908C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention