BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 11677540 · Received April 16, 2021

    Report

    Report Number
    2522007-2021-00016
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 26, 2021
    Report Date
    February 22, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT DEVICES: MERIT MEDICAL EN SNARE, OSYPKA CATCHER SNARE. PMA/510(K): K141148.

    Description of Event or Problem · 1

    ACCORDING TO COMPLAINT (B)(4) IDENTIFIED IN (B)(6), AN ADVERSE EVENT OCCURRED INVOLVING A COOK EVOLUTION 13 FR DEVICE. IT WAS REPORTED THAT STRONG ADHESION WAS OBSERVED NEAR THE TIP OF THE LEAD WITHIN THE RIGHT VENTRICLE OF PATIENT AND THE LR-EVN-13.0-RL WAS INSERTED INTO THE LEFT SUBCLAVIAN ARTERY. PRIOR TO USE OF LR-EVN-13.0-RL, LR-EVN-11.0-RL AND LR-TSS-11.0 COOK DEVICES WERE USED DURING PROCEDURE AS WELL. ADDITIONALLY, OSYPKA¿S CATCHER SNARE WAS INSERTED AT THE FEMORAL ARTERY. AS STATED BY THE COMPLAINT; ¿THE USER TRIED TO KEEP THE EVOLUTION AND LEAD ALIGNED WHILE GRABBING THE LEAD WITH THE SNARE¿. DURING THIS TIME THE LEAD BROKE AND THE TIP OF LEAD REMAINED INSIDE PATIENT, USING MERIT MEDICAL¿S EN SNARE AND OSYPKA¿S ROSS CAPTURE OF THE LEAD TIP WAS ATTEMPTED BUT FAILED. AFTER ABORTING PROCEDURE, USER CONFIRMED DECREASING BLOOD PRESSURE AND CARDIAC TAMPONADE OCCURRED. AFTER PERICARDIAL DRAINAGE, THE BLEEDING SITE COULD NOT BE IDENTIFIED. IT WAS REPORTED THAT NO HEART SURGEON WAS ON DUTY THAT NIGHT, BUT USER JUDGED THAT IT WAS A SAFER OPTION TO OPEN THE CHEST TO STOP BLEEDING. THE BLEEDING SITE WAS THEN CONFIRMED IN THE RIGHT VENTRICLE WITH HEMOSTASIS SUCCESSFULLY RESOLVED. SALES REP'S COMMENT(HE ATTENDED THE PROCEDURE): AFTER STARTING TO USE THE LR-EVN-13.0-RL , THE DOCTOR SEEMED TO STRUGGLE TO MOVE THE DEVICE FORWARD, SO IT FELT LIKE THE DOCTOR HAD DAMAGED SOMEWHERE IN THE PATIENT'S HEART. HOWEVER, SINCE THE BLOOD PRESSURE DROPPED OVER TIME AFTER THE LEAD WAS REMOVED, IT IS UNKNOWN AT WHAT TIMING AND WHICH DEVICE HAD A MAJOR IMPACT ON THE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575273 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention