BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 25312479 · Received May 28, 2026

    Report

    Report Number
    3007835716-2026-00076
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION IDENTIFIED A PINHOLE IN THE PROXIMAL PORTION OF THE BALLOON. IT WAS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LOCALIZED CONTACT WITH A LESION; HOWEVER, THE DETAILED ROOT CAUSE COULD NOT BE DETERMINED. NO ABNORMALITIES WERE FOUND IN THE PRODUCTION RECORDS. THE INSTRUCTIONS FOR USE (IFU) INCLUDE GENERAL USAGE INSTRUCTIONS, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION INTENDED TO INFORM USERS OF POTENTIAL COMPLICATIONS AND SIMILAR EVENTS THAT MAY OCCUR. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE PRODUCT IS DEFECTIVE. ALTHOUGH NO PATIENT 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

    A BALLOON RUPTURE WAS REPORTED DURING THE PROCEDURE. THE BALLOON USED TO TREAT A 90% STENOTIC, CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (SEGMENT 7) RUPTURED DURING INFLATION AT 16 ATM. IT WAS SUBSEQUENTLY REPLACED WITH A NEW DEVICE, AND THE PROCEDURE WAS CONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132336 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX NIPRO VASCULAR CORPORATION APN32513 ANH250411C

    Patients

    Seq Age Sex Outcome Treatment
    1