BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK NEO¿

    MDR report key: 23512615 · Received November 10, 2025

    Report

    Report Number
    2024168-2025-11440
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 19, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232527
    PMA / PMN Number
    K220634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION, FUNCTIONAL TESTING, AND SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED LEAK WAS CONFIRMED. THE REPORTED BALLOON RUPTURED WAS UNABLE TO BE CONFIRMED; HOWEVER, THE NOTED TEAR IN THE OUTER MEMBER AND THE REPORTED LEAK IS LIKELY WHAT WAS PERCEIVED AS THE REPORTED BALLOON RUPTURE SINCE THE BALLOON WOULD NOT HOLD PRESSURE. 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. THE INVESTIGATION DETERMINED A POTENTIAL PRODUCT QUALITY ISSUE BASED ON EVALUATION OF THE RETURNED UNIT AND THE REPORTED LEAK AND NOTED TEAR IN THE OUTER MEMBER NEAR GUIDE WIRE EXIT NOTCH. SEM ANALYSIS DETERMINED THE CATHETER FAILURE APPEARS TO HAVE BEEN CAUSED BY MECHANICAL DAMAGE, INITIATED FROM THE INNER DIAMETER (ID) SURFACE. SIGNIFICANT ABRASION/GOUGING OF MATERIAL WAS FOUND IN THE ID SURFACE, WEAKENING THE WALL OF THE CATHETER UNTIL FAILURE OCCURRED. ADDITIONALLY, THE BALLOON RUPTURED WAS UNABLE TO BE CONFIRMED; HOWEVER, THE NOTED TEAR IN THE OUTER MEMBER AND THE REPORTED LEAK IS LIKELY WHAT WAS PERCEIVED AS THE REPORTED BALLOON RUPTURE SINCE THE BALLOON WOULD NOT HOLD PRESSURE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3, B6: DATES ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 3.00X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS INFLATED BUT SALINE SOLUTION WAS LEAKING FROM THE SIDE OF THE CATHETER AND THE BALLOON RUPTURED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273561 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400300-15 50520G2 08717648232527

    Patients

    Seq Age Sex Outcome Treatment
    1