BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 23712792 · Received December 4, 2025

    Report

    Report Number
    3007835716-2025-00125
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 31, 2025
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    PNO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT AND THE COMBINED USE GUIDEWIRE WERE RETURNED FOR INVESTIGATION. THE TIP AND THE COVER TUBE WERE TORN FROM THE CATHETER AND THEY ARE STUCKING ON THE COMBINED USE GUIDEWIRE. WE CONFIRMED THAT THE COVER TUBE HAS ADHESIVE MARKS THAT MEANS THE PRODUCTION WAS CONDUCTED NORMALLY. REGARDING THE BALLOON PART WAS NOT RUPTURED AND NO ABNORMALITIES FOUND. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. IT IS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY EXSESSIVE TENSILE FORCE LOADED ON THE TIP AND THE COVER TUBE PART BY SOME REASON DURING THE OPERATION, 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 USERS 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. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE OPERATION. WE ARE REPORTING THIS EVENT BECAUSE SEPARATION OF THE PART OF THE CATHETER DURING OPERATION IN THE PATIENT BODY THAT CAN LEAD TO EMBOLISM BY IT REMAIN IN THE BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP AND COVER TUBE OF THE BALLOON HAD TORN OFF. THE CATHETER WAS USING ON OPERATION BUT THE DOCTOR FELT AS GOTTEN CAUGHT ON SOMETHING. THEN THE DOCTOR PULLED IT BACK TO REMOVE IT BUT THERE WAS CONSIDERABLE RESISTANCE INSIDE THE SHEATH. AFTER THAT THE BALLOON WAS REMOVED FROM THE BODY THEN THE DOCTOR COMFIRMED THE TIP OF THE BALLOON HAD DAMAGE. THEN IT WAS REPLACED WITH A NEW IDENTICAL PRODUCT AND THE OPERATION WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879678 NSE PTA BALLOON DILATATION CATHETER Catheter, percutaneous, cutting/scoring PNO GOODMAN CO., LTD. NU18-09050020 NPAW230626A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention