BEUDAMED
    FDA Adverse Event Death Summary report: N

    RL CONTROLLED-ROTATION DILATOR SHEATH

    MDR report key: 20211496 · Received September 13, 2024

    Report

    Report Number
    MW5159556
    Event Type
    Death
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    August 30, 2024
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV} LEAD DUE TO BACTEREMIA. (B)(6) LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION. ALTERNATING BETWEEN A (B)(6) GLIDELIGHT LASER SHEATH AND A COOK MEDICAL EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH ON THE LV LEAD, THE INSULATION ON THE LV LEAD BROKE FREE AND CAME OUT OF THE POCKET, LEAVING THE LLD AND THE VERY TIP OF THE LV LEAD. THE COOK EVOLUTION WAS AGAIN USED TO ADVANCE DOWN THE LLD, TO ATTEMPT REMOVAL OF THE LV LEAD TIP. HOWEVER, WHILE THE COOK EVOLUTION WAS IN USE, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. DESPITE THE RESCUE EFFORTS, THE PATIENT DID NOT SURVIVE. ALTHOUGH (B)(6) DEVICES WERE IN USE DURING THE PROCEDURE, THE COOK EVOLUTION WAS THE LAST DEVICE USED WHEN THE HEMODYNAMIC COMPROMISE OCCURRED AND THE INJURY WAS NOTED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564295 RL CONTROLLED-ROTATION DILATOR SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death LV LEAD| RV LEAD