BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 24921336 · Received April 19, 2026

    Report

    Report Number
    3007835716-2026-00047
    Event Type
    Malfunction
    Date Received
    April 19, 2026
    Date of Event
    November 28, 2025
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE PRODUCT WAS NOT RETURNED, A DETAILED INVESTIGATION USING THE PRODUCT COULD NOT BE PERFORMED. IT WAS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LOCAL CONTACT WITH A LESION; HOWEVER, THE DETAILED ROOT 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 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.

    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 DURING THE PROCEDURE. THE BALLOON WAS USED TO TREAT A 90% STENOTIC, SEVERELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. THE BALLOON WAS DELIVERED WITH AN EXTENSION CATHETER; HOWEVER, IT RUPTURED DURING INFLATION. THE PRODUCT WAS REMOVED, ROTA TREATMENT WAS PERFORMED, AND THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212903 APERTA NSE CORONARY DILATATION CATHETER CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX NIPRO VASCULAR CORPORATION APN32513 ANH240522B

    Patients

    Seq Age Sex Outcome Treatment
    1