BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II

    MDR report key: 20956442 · Received December 17, 2024

    Report

    Report Number
    2024168-2024-14904
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 31, 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 IS LIKELY THAT MANIPULATION OF THE WIRE, WHEN RESISTANCE WAS MET, CONTRIBUTED TO THE REPORTED PEELED/DELAMINATED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4 CORRECTION: LOT #UPDATED TO 3080772.

    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

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 95% STENOSED. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON AND THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE MULTIPLE TIMES ANATOMY. PEELED OFF SEGMENTS WERE OBSERVED AT THE CORE OF THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED WITHOUT ISSUE. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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
    227262 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1009664 3080772 08717648118715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown