BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK NEO¿

    MDR report key: 23577366 · Received November 17, 2025

    Report

    Report Number
    2024168-2025-11560
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232411
    PMA / PMN Number
    K220634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THERE WAS NO LEAK NOTED DURING PREPARATION, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IN THIS CASE, IT IS LIKELY THAT THE BALLOON INTERACTED WITH THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANATOMY RESULTING IN THE REPORTED BALLOON RUPTURE DURING INFLATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 75% STENOSED. THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316807 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400250-15 50730G1 08717648232411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown