BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 24994177 · Received April 27, 2026

    Report

    Report Number
    3007835716-2026-00055
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 9, 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THERE WAS A PINHOLE FOUND IN PROXIMAL PART OF THE BALLOON. IT IS CONSIDERED THAT THE REPORTED EVENT WAS CAUSED BY LOCAL CONTACT WITH A LESION, BUT THE DETAILED 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 YOU 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 HAVE BEEN REPORTED, WE ARE REPORTING THIS EVENT CONSERVATIVELY BECAUSE BALLOON RUPTURE OR SHAFT LEAKAGE IS KNOWN TO POTENTIALLY CAUSE ADVERSE EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE BALLOON WAS USED TO TREAT A 100% STENOTIC LESION IN THE RIGHT SFA AFTER THE LESION WAS CROSSED USING A CROSSING CATHETER. THE BALLOON RUPTURED DURING INFLATION AT 20 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
    46849 APERTA NSE PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO NIPRO VASCULAR CORPORATION LW18-14540100 AWDD25G052

    Patients

    Seq Age Sex Outcome Treatment
    1