BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE COMMAND

    MDR report key: 22501481 · Received July 14, 2025

    Report

    Report Number
    2024168-2025-07241
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648176685
    PMA / PMN Number
    K122573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO DIFFICULT TO REMOVE INCLUDE, BUT ARE NOT LIMITED TO, OUTER DIAMETER OF THE GUIDE WIRE, CHALLENGING ANATOMY, DEVICE SUPPORT, BUILDUP OF PROCEDURAL CONTAMINANTS, USER TECHNIQUE, AND/OR DAMAGE TO THE GUIDE WIRE WHICH LIKELY LED TO THE REPORTED GUIDE WIRE BREAK. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. B1 CORRECTION: ADVERSE EVENT REMOVED B2 CORRECTION: REQUIRED INTERVENTION REMOVED D4 CORRECTION: LOT NUMBER UPDATED FROM UNKNOWN TO 5041071 H1 CORRECTION: SERIOUS INJURY 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 THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS NOTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE FROM THE LASER ATHERECTOMY DEVICE AND SLIGHT FORCE WAS APPLIED. THE GUIDEWIRE WAS NOTED TO BREAK BUT WAS HELD TOGETHER BY THE COILS, AND THE LASER ATHERECTOMY DEVICE, AND GUIDE WIRE WERE PULLED INTO THE SHEATH WHERE THEY ALL WERE REMOVED AS A SINGLE UNIT FROM THE ANATOMY. AT THIS POINT, THE PHYSICIAN WAS ABLE TO REWIRE THE VESSEL, PERFORM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND COMPLETE THE PROCEED AS ORIGINALLY INTENDED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 300CM HT COMMAND GUIDEWIRE (GW) WAS USED WITH A NON-ABBOTT LASER ATHERECTOMY DEVICE; HOWEVER DURING THE PROCEDURE THE WIRE WAS NOTED TO BREAK IN ONE LOCATION AND COMPLETELY SEPARATE IN ANOTHER LOCATION. THE GW WAS REMOVED AND THE SEPARATION PORTION WERE RECEIVED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396062 HI-TORQUE COMMAND WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 2078175 5041071 08717648176685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention LASER ATHERECTOMY CATHETER: PHILIPS LASER CATHETER