BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT

    MDR report key: 20544898 · Received October 28, 2024

    Report

    Report Number
    2024168-2024-12610
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 7, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    PMA / PMN Number
    K152709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION COULD NOT BE CONFIRMED. 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 WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED MATERIAL SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE FELT STRIPPED (MATERIAL SEPARATION). ANALYSIS OF THE RETURNED WIRE WAS UNABLE TO CONFIRM A MATERIAL SEPARATION. THE WIRE WAS NOTED TO HAVE MISALIGNED AND STRETCHED COILS. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE WIRE ENCOUNTERING RESISTANCE DURING USE. IN THIS CASE, IT IS UNKNOWN WHAT CAUSE THE WIRE TO BE PERCEIVED AS ¿STRIPPED.¿ THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4 - LOT # UPDATED FROM UNKNOWN TO: 4061071. D4 - PRIMARY UDI NUMBER UPDATED FROM(B)(4).

    Additional Manufacturer Narrative · 0

    D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN. 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 INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS DID NOT CONFIRM A SEPARATION OF THE GUIDE WIRE. THE COILS WERE MISALIGNED SPORADICALLY THROUGHOUT THE ENTIRE LENGTH OF THE DEVICE AND THE TIP COILS WERE STRETCHED OUT DISTAL FROM THE PROXIMAL SOLDER, FOR A LENGTH OF 4 MILLIMETERS (MM). THE STRETCHED COILS ARE LIKELY WHAT WAS REPORTED BY THE ACCOUNT AS THE GUIDE WIRE BEING STRIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR LEFT VENTRICULAR (PLV) ARTERY. THE BMW HYDRO GUIDE WIRE WAS ADVANCED TO THE DISTAL PLV BEYOND THE OCCLUSION WITH NO DISTAL FLOW. THE 4.0X8MM AND 2.5X15MM BALLOON CATHETERS WERE UNABLE TO CROSS THE LESION. THE BMW GUIDE WIRE WAS EXCHANGED FOR A WHISPER GUIDE WIRE TO CONTINUE THE PROCEDURE. 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
    1042591 HI-TORQUE BALANCE MIDDLEWEIGHT WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1001780-HC 4061071

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male