BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 24797479 · Received April 7, 2026

    Report

    Report Number
    3007835716-2026-00035
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 5, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THERE WAS A RUPTURE FOUND THROUGHOUT 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 USERS 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 BALLOON RUPTURE OCCURRED. THE BALOON WAS USED FOR A CALCIFIED LESION WITH 95% STENOSIS OF THE RCA #3, BUT THE LESION COULD NOT BE PASSED THROUGH. THEREFORE, THE BALLOON WAS ADVANCED USING THE LEOPARD-CRAWL TECHNIQUE, BUT IT SUBSEQUENTLY RUPTURED. 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
    60635 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX NIPRO VASCULAR CORPORATION APN30013 ANH250422B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown