BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 25010515 · Received April 27, 2026

    Report

    Report Number
    3007835716-2026-00059
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 8, 2026
    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

    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

    A BALLOON RUPTURE WAS REPORTED DURING THE PROCEDURE. THE BALLOON WAS USED TO TREAT A 90% STENOTIC LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (SEGMENTS 6-7) AND RUPTURED DURING THE SECOND INFLATION AT THE RATED BURST 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
    497752 APERTA NSE CORONARY DILATATION CATHETER CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX NIPRO VASCULAR CORPORATION APN35013 ANH250630A

    Patients

    Seq Age Sex Outcome Treatment
    1