BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK¿

    MDR report key: 23409937 · Received October 28, 2025

    Report

    Report Number
    2024168-2025-11271
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 7, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648138102
    PMA / PMN Number
    K180040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 NOTED THAT THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED WHICH CAN INDICATE THE HYPOTUBE WAS KINKED AND THEN SEPARATED. IN THIS CASE, IT IS LIKELY THAT THE BDC WAS INADVERTENTLY MISHANDLED DURING REMOVAL FROM THE PACKAGING 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: D4 - LOT NUMBER 40923G1 WAS REMOVED.

    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 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) PACKAGING WAS ALL INTACT; HOWEVER, THE SHAFT WAS COMPLETELY BENT, SNAPPING INTO TWO PIECES. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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
    1587981 MINI TREK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1012269-15 50221G2 08717648138102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown