BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 23179945 · Received September 30, 2025

    Report

    Report Number
    2522007-2025-00024
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 18, 2025
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRE
    PMA / PMN Number
    K141148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AND THE LOT OF THE DEVICE WAS UNKNOWN. D4 - UDI NUMBER: UNKNOWN. E1 - FIRST NAME: UNKNOWN. E1 - LAST NAME: UNKNOWN. E1 - TITLE: UNKNOWN. E1 - PHONE: (B)(6). E1 - ZIP/POSTAL CODE: (B)(6). THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THE PATIENT WAS A FEMALE IN HER 30S WITH A PACEMAKER-DEFIBRILLATOR PLACED IN THE RIGHT VENTRICLE THROUGH THE LEFT ANTERIOR CHEST. THE USER CREATED A ROUTE WITH A PHILIPS'S LOCKING STYLET, THEN USED A 14 FR LASER AND AN EVOLUTION 11 FR DEVICE AND THEN A 16 FR LASER. WHILE USING THE 16 FR LASER, THE USER NOTICED THAT A SHUNT INTO THE ARTERY HAD FORMED AROUND THE BRACHIOCEPHALIC VEIN. THEREFORE, THE LEAD REMOVAL VIA VEIN WAS ABANDONED, AND A SURGICAL OPERATION WAS CONDUCTED TO OPEN THE CHEST, AND THE TARGET LEAD WAS REMOVED. THE USER INSERTED A LEAD LOCKING DEVICE (LLD EZ) INTO THE A LEAD BUT COULD NOT ADVANCE IT TO THE TIP, AND THE USER STABILIZED IT UNDER THE J SHAPE. THE USER INSERTED A LLD #2 INTO THE V LEAD AND STABILIZED IT AT THE TIP AND PULLED THE HV CABLE WITH A BULLDOG (LR-LED01/N211449). THEN, THE USER STARTED TO FREE THE A LEAD WITH A GLIDELIGHT 12F, BUT IT GOT STUCK BELOW THE CLAVICLE. THEREFORE, THE USER CHANGED THE TARGET TO THE V LEAD AND STARTED TO FREE IT BY A GLIDELIGHT 14F. SINCE IT GOT STUCK WHEN IT ADVANCED A LITTLE, THE USER REPLACED THE GLIDELIGHT 14F WITH AN EVOLUTION 11F(LR-EVN-11.0-RL/N218027) AND STARTED AGAIN TO FREE THE V LEAD. THE ADHESION BETWEEN THE A LEAD AND V LEAD WERE SIGNIFICANTLY STUCK JUST BEFORE DESCENDING INTO THE SVC FROM BELOW THE CLAVICLE. THE USER CONTINUED TO FREE THE A AND V LEADS IN TURNS WITH EVOLUTION 11F. HOWEVER, THEY STUCK AT THE SAME LOCATION, SO THE USER SWITCHED TO GLIDELIGHT 16F AND ATTEMPTED TO FREE THE V LEAD AGAIN. AFTER A LITTLE WHILE, THE BLOOD PRESSURE DECREASED, AND THE USER NOTICED THAT THE BLOOD LEAKING FROM THE INSERTION LOCATION BEGAN TO CHANGE FROM VENOUS BLOOD TO ARTERIAL BLOOD. THE USER PERFORMED AN AORTA CONTRAST STUDY AND FOUND THAT THE CONTRAST AGENT WAS SPREADING TO THE UPPER PART OF THE AORTA. IT WAS THEN DECIDED TO OPEN THE CHEST. LACERATIONS WERE FOUND IN THE BRACHIOCEPHALIC ARTERY AND SUBCLAVIAN VEIN, WHICH WERE SUTURED, AND HEMOSTASIS WAS ACHIEVED. UNDER EXTRACORPOREAL CIRCULATION, BOTH A LEAD AND V LEAD WERE REMOVED WITH AN EVOLUTION 13F (LOT#: N212877) AND A STEADY SHEATH (LOT#: N213941).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154934 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC. G23746 N218027

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention 16FR LASER.| GLIDELIGHT 12F.| GLIDELIGHT 14FR.| LLD EZ.| LR-LED01.| PHILLIPS LOCKING STYLET.