BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT¿

    MDR report key: 23977439 · Received January 6, 2026

    Report

    Report Number
    2024168-2026-00104
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 16, 2025
    Report Date
    March 19, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648025969
    PMA / PMN Number
    K152709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE CAPTURED UNDER SEPARATE MEDWATCH NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO DAMAGE OBSERVED PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE INCURRED DURING MANUFACTURING, DAMAGE INCURRED DURING SHIPMENT, OR INADVERTENT MISHANDLING DURING UNPACKING OR PREPARATION. ADDITIONALLY, TWO STERILE/UNUSED DEVICES WITH LOT # 5091073 WERE TESTED SUCCESSFULLY WITH NO ANOMALIES NOTED. AS SUCH, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. D9: CORRECTED DEVICE AVAILABLE FOR EVALUATION FROM YES TO NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS REMOVED FROM THE DISPENSER COIL, IT WAS NOTED THAT THE TIP WAS DAMAGED AND THE WELD WAS POORLY DONE. THE WIRE TIP SEEMED WORN OUT. TWO SAME GUIDE WIRES HAD THE SAME ISSUE. ULTIMATELY A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40519 HI-TORQUE BALANCE MIDDLEWEIGHT¿ WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1001780-HC 5091073 08717648025969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown