BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE

    MDR report key: 23599988 · Received November 19, 2025

    Report

    Report Number
    2024168-2025-11633
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648013959
    PMA / PMN Number
    K982876
    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. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT REPORTED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. FACTORS THAT CONTRIBUTE TO DIFFICULTY REMOVING THE GUIDE WIRE INCLUDE, BUT ARE NOT LIMITED TO, OUTER DIAMETER OF THE GUIDE WIRE, CHALLENGING ANATOMY, DEVICE SUPPORT, BUILDUP PROCEDURAL CONTAMINANTS, USER TECHNIQUE, AND/OR DAMAGE TO THE GUIDE WIRE. IN THIS CASE, IT WAS REPORTED THAT WHILE RETRACTING THE STEELCORE, IT GOT CAUGHT ON THE SENSOR DEVICE AND PULLED THE SENSOR INTO THE PULMONARY ARCH. 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. D4: CATALOG # UPDATED FROM 1003282 TO UNK. D4: LOT # UPDATED FROM 2092761 TO UNKNOWN. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    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, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. FACTORS THAT CONTRIBUTE TO DIFFICULTY REMOVING THE GUIDE WIRE INCLUDE, BUT ARE NOT LIMITED TO, OUTER DIAMETER OF THE GUIDE WIRE, CHALLENGING ANATOMY, DEVICE SUPPORT, BUILDUP PROCEDURAL CONTAMINANTS, USER TECHNIQUE, AND/OR DAMAGE TO THE GUIDE WIRE. THE DEVICE WAS USED AFTER EXPIRATION DATE. A REVIEW OF THE LOT HISTORY RECORD INDICATED AN EXPIRATION DATE (USE BY DATE) OF 08-31-2024 AND THE PROCEDURE DATE WAS (B)(6) 2025 APPROXIMATELY FOURTEEN MONTHS POST EXPIRATION. IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) FOR HT GUIDE WIRES INDICATES USE BY DATE SYMBOL, WHICH IS NEXT TO THE EXPIRATION DATE. THE IFU DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIOMEMS HEART FAILURE (HF) SYSTEM WAS DEPLOYED OVER AN UNSPECIFIED HI-TORQUE (HT) STEELCORE 18 GUIDE WIRE IN THE LEFT PULMONARY ARTERY (PA). UPON REMOVAL OF THE HT STEELCORE GUIDE WIRE, THE CARDIOMEMS HF SYSTEM GOT CAUGHT AND WAS PULLED INTO THE PULMONARY ARCH. THE HT STEELCORE GUIDE WIRE WAS ABLE TO BE REMOVED INDEPENDENTLY. A NON-ABBOTT PA CATHETER WAS USED TO RE-ADVANCE [REPOSITION] THE CARDIOMEMS HF SYSTEM. THE CARDIOMEMS WAS PUSHED INTO THE RIGHT PA ; NOT THE DESIRED IMPLANT SITE, WHERE CALIBRATION WAS PERFORMED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262988 HI-TORQUE STEELCORE WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. UNK 2092761 08717648013959

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female