BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK NEO¿

    MDR report key: 22012047 · Received May 13, 2025

    Report

    Report Number
    2024168-2025-04983
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232527
    PMA / PMN Number
    K220634
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULTY ADVANCING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CONTEXT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTY ADVANCING THE DEVICE, SEPARATION AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT WAS REPORTED BY THE ACCOUNT THAT THE DEVICE WAS USED TO PERFORM THE KISSING BALLOON TECHNIQUE (KBT). IT SHOULD BE NOTED THAT WHEN USING TWO DEVICES TOGETHER OR PERFORMING THE KISSING BALLOON TECHNIQUE (KBT), THE ACCESS NARROWS THROUGH THE GUIDING CATHETER DUE TO THE MULTIPLE DEVICES INSERTED AT ONCE. WHEN USING TWO DEVICES OR PERFORMING THE KBT IT IS RECOMMENDED THAT THE LARGER BALLOON BE PLACED FIRST AND A LARGER SIZE FRENCH (FR), LIKE A 7FR GUIDE BE USED. IN THIS CASE, IT IS LIKELY THAT THE USE OF THE KBT TECHNIQUE CONTRIBUTED TO THE REPORTED DIFFICULTY DURING ADVANCEMENT. RETURN DEVICE ANALYSIS NOTED THAT THE GUIDE WIRE EXIT NOTCH WAS TORN LONGITUDINALLY. THE TEARING OF THE GUIDE WIRE EXIT NOTCH APPEARS TO HAVE RESULTED FROM AN INTERACTION WITH THE GUIDE WIRE. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. ADDITIONALLY, THE MATERIAL AT THE NOTED SEPARATION WAS JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). IT IS LIKELY THAT THE SEPARATION RESULTED FROM MANIPULATION OF THE DEVICE DURING USE AS DIFFICULTY WAS ENCOUNTERED. ADDITIONAL TREATMENT WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE DEVICE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    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

    SUBSEQUENTLY TO THE INITIALLY FILED REPORT, IT WAS NOTED THAT THE UNSPECIFIED NC TREK NEO WAS A 2.0X15MM NC TREK NEO BDC. THE KISSING BALLOON TECHNIQUE WAS NOT ATTEMPTED AGAIN AND THE 2.0X15MM NC TREK BDC WAS INFLATED IN THE DIAGONAL BRANCH. THE 3.0X15MM NC TREK NEO WAS USED FOR RE-PROXIMAL OPTIMIZATION TECHNIQUE (RE-POT). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 80% STENOSED. DURING ADVANCEMENT OF A 3.00X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH AN UNSPECIFIED NC TREK NEO BALLOON AS BOTH BALLOONS WERE USED TO PRE-DILATE THE LESION USING THE KISSING BALLOON TECHNIQUE. DURING REMOVAL OF THE 3.00X15MM NC TREK NEO BDC, THE SHAFT OF THE BDC SEPARATED AND WAS REMOVED WITH ANOTHER UNSPECIFIED GUIDEWIRE BY TANGLING IT WITH THE FIRST GUIDEWIRE. A NEW 3.0X15 NC TREK NEO WAS USED TO REPLACE THE FIRST NC TREK NEO BDC AND COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368163 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400300-15 50210G1 08717648232527

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention