BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 19790257 · Received July 22, 2024

    Report

    Report Number
    3007835716-2024-00231
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 5, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, AND THE INVESTIGATION WAS UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM. IT IS CONSIDERED THAT THE REPORTED EVENT WAS CAUSED BY LOCAL CONTACT WITH A LESION, 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 NO COMPLICATIONS HAVE BEEN REPORTED, WE ARE REPORTING THIS EVENT CONSERVATIVELY BECAUSE BALLOON RUPTURE OR SHAFT LEAKAGE IS KNOWN TO POTENTIALLY CAUSE ADVERSE EVENTS.

    Description of Event or Problem · 0

    THE BALLOON WAS RUPTURED 10 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737367 NSE PTA BALLOON DILATATION CATHETER Catheter, percutaneous, cutting/scoring PNO GOODMAN CO., LTD. NR14-15540020 NQHR231013B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose