BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II

    MDR report key: 20968018 · Received December 18, 2024

    Report

    Report Number
    2024168-2024-14993
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 29, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648118715
    PMA / PMN Number
    K152709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE PRODUCTION RECORDS AND THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO INDICATION OF A LOT SPECIFIC ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT WAS REPORTED THAT THE GUIDE WIRE ENCOUNTERED RESISTANCE WITH THE PATIENT¿S MODERATELY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED LESION RESULTING IN THE REPORTED RESISTANCE DURING ADVANCEMENT AND REMOVAL. ADDITIONALLY, IT WAS REPORTED THAT THE WIRE WAS OBSERVED TO HAVE AN IRREGULAR TEXTURE ONCE OUT OF THE ANATOMY. IT IS LIKELY THAT THE GUIDE WIRE SUSTAINED DAMAGE DURING ITS INTERACTION WITH THE ANATOMY, RESULTING IN THE REPORTED IRREGULAR APPEARANCE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. D4: MODEL # CORRECTION FROM UNK UNIVERSAL BMW II TO 1009664. D4: CATALOG # CORRECTION FROM UNK UNIVERSAL BMW II TO 1009664. D4: LOT# CORRECTION: FROM UNKNOWN TO 4032771. D4: PRIMARY UDI NUMBER CORRECTION: FROM UNKNOWN TO (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND OBTUSE MARGINAL CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE -LAD WAS TREATED FIRST AND WHEN THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS USED IN THE OBTUSE MARGINAL ARTERY THERE WAS RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH THE ANATOMY. UPON REMOVAL, THE COATING OF THE WIRE WAS OBSERVED TO BE UNEVEN. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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
    2083604 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1009664 4032771 08717648118715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown