BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 25157493 · Received May 13, 2026

    Report

    Report Number
    3007835716-2026-00063
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 16, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE PRODUCT WAS NOT RETURNED, A DETAILED INVESTIGATION USING THE PRODUCT COULD NOT BE PERFORMED. IT WAS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LOCAL CONTACT WITH A LESION; HOWEVER, THE DETAILED ROOT CAUSE COULD NOT BE IDENTIFIED. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. 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. ALTHOUGH NO COMPLICATIONS WERE REPORTED, THIS EVENT IS BEING REPORTED PURSUANT TO 21 CFR PART 803.50(A)(2), AS BALLOON RUPTURE OR SHAFT LEAKAGE IS KNOWN TO HAVE THE POTENTIAL TO CAUSE ADVERSE EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE BALLOON WAS USED TO TREAT A CALCIFIED LESION IN AN ARTERIOVENOUS FISTULA (AVF) AND RUPTURED DURING THE SECOND INFLATION AT 10 ATM. THE BALLOON WAS THEN REPLACED, AND THE PROCEDURE WAS CONTINUED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535416 NSE PTA BALLOON DILATATION CATHETER Catheter, percutaneous, cutting/scoring PNO NIPRO VASCULAR CORPORATION NU18-05050020 NPHW250403A

    Patients

    Seq Age Sex Outcome Treatment
    1