BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 25213720 · Received May 19, 2026

    Report

    Report Number
    3007835716-2026-00068
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 23, 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 A BALLOON RUPTURE OCCURRED. THE BALLOON USED TO TREAT A SEVERELY CALCIFIED LESION IN THE POPLITEAL ARTERY (POP) RUPTURED DURING INFLATION AT 18 ATM. IT WAS SUBSEQUENTLY REPLACED, AND THE PROCEDURE WAS CONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133592 APERTA NSE PTA BALLOON DILATATION CATHETER Catheter, percutaneous, cutting/scoring PNO NIPRO VASCULAR CORPORATION AW18-14560040 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1