BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 25179822 · Received May 15, 2026

    Report

    Report Number
    3007835716-2026-00065
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 20, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS NOT BEEN COMPLETED YET; THEREFORE, THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. THIS IS AN INITIAL REPORT, AND THE RESULTS OF THE INVESTIGATION WILL BE DESCRIBED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE BALLOON USED FOR A CALCIFIED LESION IN SFA-POP RUPTURED DURING INFLATION AT LESS THAN NOMINAL PRESSURE. THEN IT WAS REPLACED WITH A NEW PRODUCT AND THE OPERATION WAS CONTINUED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353490 APERTA NSE PTA BALLOON DILATATION CATHETER Catheter, percutaneous, cutting/scoring PNO NIPRO VASCULAR CORPORATION LW18-14540100 AWDD25H009

    Patients

    Seq Age Sex Outcome Treatment
    1