BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE COMMAND¿

    MDR report key: 24394036 · Received February 19, 2026

    Report

    Report Number
    2024168-2026-00705
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648212130
    PMA / PMN Number
    K172073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED POLYMER COATING DAMAGE WAS CONFIRMED. THE REPORTED FAILURE TO CROSS WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT. 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, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. FACTORS THAT MAY CONTRIBUTE TO FAILURE TO ADVANCE INCLUDE, BUT ARE NOT LIMITED TO, CHALLENGING ANATOMY, DEVICE SUPPORT, BUILDUP OF PROCEDURAL CONTAMINANTS, USER TECHNIQUE, AND/OR DAMAGE TO THE GUIDE WIRE. IN THIS CASE, THE CHALLENGING ANATOMY CONTRIBUTED TO THE REPORTED DIFFICULTIES AS IT WAS REPORTED THAT THE GUIDE WIRE FAILED TO CROSS DUE TO ANATOMY WHICH LED TO THE REPORTED AND OBSERVED DAMAGES OF THE POLYMER COATING. 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. CORRECTION: D4 - MODEL # 1060002A REMOVED. CORRECTION: D4 - LOT # UPDATED 5061371 REMOVED CORRECTION: PRIMARY UDI NUMBER: (B)(4) REMOVED. CORRECTION: H6 - MEDICAL DEVICE PROBLEM CODE 2920 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

    SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE GW WAS A HT COMMAND 18 ST GW. THE GW FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. WHEN THE GW WAS REMOVED FROM THE ACCESS NEEDLE, THE COATING WAS NOTED TO HAVE PEELED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROCEDURE WAS TO TREAT DE NOVO LESION IN THE TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE HT COMMAND 14 GUIDE WIRE (GW) WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY, AND THE GW COATING WAS NOTED TO BE PEELING, BUT REMAINED ATTACHED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614405 HI-TORQUE COMMAND¿ WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1013731 5012161 08717648212130

    Patients

    Seq Age Sex Outcome Treatment
    1