BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK¿

    MDR report key: 23990499 · Received January 7, 2026

    Report

    Report Number
    2024168-2026-00132
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 16, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648138287
    PMA / PMN Number
    K180040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. RETURN DEVICE ANALYSIS NOTES THAT THE HYPOTUBE FRACTURE FACE WAS IN OVAL SHAPED WHICH CAN INDICATE THE HYPOTUBE WAS KINKED AND THEN SEPARATED. THERE WAS NO DAMAGE NOTED TO THE BALLOON DILATATION CATHETER (BDC) DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IN THIS CASE, IT IS LIKELY THAT THE BDC WAS INADVERTENTLY MISHANDLED DURING PREPARATION AND/OR ADVANCEMENT SUCH THAT THE SHAFT BECAME KINKED AND UPON FURTHER MANIPULATION IT ULTIMATELY SEPARATED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: G4 - PMA/510(K) #: UPDATED FROM K103110 TO K180040.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 2.5X12 MM TREK CATHETER BROKE IN TWO PIECES, APPROXIMATELY 30CM PROXIMAL TO THE GUIDEWIRE EXIT NOTCH DURING A CASE TO TREAT THE OSTIAL RAMUS CORONARY ARTERY. THE ACCESS SITE WAS VIA THE RIGHT RADIAL ARTERY WITH A 6F CORDIS SHEATH. THOUGH REQUESTED, IT IS UNKNOWN HOW THE SEPARATED SEGMENT WAS REMOVED FROM THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53423 TREK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1012272-12 41030G1 08717648138287

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown