BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK¿

    MDR report key: 23279153 · Received October 15, 2025

    Report

    Report Number
    2024168-2025-11066
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 14, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648138287
    PMA / PMN Number
    K180040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED BREAK WAS NOT CONFIRMED; HOWEVER, THE DEVICE WAS RETURNED SEPARATED, WHICH IS LIKELY WHAT THE ACCOUNT PERCEIVED AS BROKEN. 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 BREAK AND NOTED SEPARATION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. RETURN DEVICE ANALYSIS NOTED THAT THE SHAFT OF THE DEVICE WAS SEPARATED. IN THIS CASE, IT IS LIKELY THAT THE NOTED SEPARATION IS WHAT THE ACCOUNT REPORTED AS BROKEN. IT IS LIKELY THAT THE SHAFT WAS INADVERTENTLY KINKED/BROKEN DURING UNPACKAGING OF THE DEVICE, GIVING THE IMPRESSION OF BROKEN AND UPON FURTHER MANIPULATION OF THE DEVICE DURING PACKAGING TO RETURN TO ABBOTT VASCULAR FOR ANALYSIS, THE SHAFT ULTIMATELY SEPARATED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE BROKEN OUT OF THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177864 TREK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1012272-12 50620G2 08717648138287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown