BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 24994889 · Received April 27, 2026

    Report

    Report Number
    3007835716-2026-00056
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 8, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 WAS USED TO TREAT A LESION AND RUPTURED DURING THE THIRD INFLATION BELOW THE NOMINAL PRESSURE. 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
    310274 NSE PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO NIPRO VASCULAR CORPORATION NU18-05060040 NPHW250116A

    Patients

    Seq Age Sex Outcome Treatment
    1