BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK NEO¿

    MDR report key: 23926220 · Received December 30, 2025

    Report

    Report Number
    2024168-2025-12282
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232701
    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 REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINTS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE WAS NO LEAK NOTED TO THE BALLOON DURING PREPARATION OR DURING THE FIRST INFLATION, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT WAS REPORTED BY THE ACCOUNT THAT THE BALLOON DILATATION CATHETER (BDC) INTERACTED WITH THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANATOMY RESULTING IN THE REPORTED DIFFICULTY ADVANCING THE DEVICE AND SUBSEQUENTLY THE BALLOON BECAME DAMAGED AND RUPTURED DURING THE SECOND 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 PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 4.00 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS ENCOUNTERED DUE TO ANATOMY. ONCE AT THE LESION, THE NC TREK NEO BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. A NEW NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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
    1769904 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400400-08 50509G1 08717648232701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown