BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 12028466 · Received June 18, 2021

    Report

    Report Number
    2522007-2021-00020
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 7, 2021
    Report Date
    February 25, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    00827002237483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K): K141148. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE (B)(6) 2021. SHORTLY AFTER STARTING PROCEDURE, THE USER NOTED MORE BLEEDING THAN USUAL, BUT BELIEVED THIS WAS NOT A MAJOR PROBLEM AT THAT TIME. AFTER BOTH THE RIGHT VENTRICULAR AND RIGHT ATRIUM LEADS WERE REMOVED, A BLOOD TRANSFUSION WAS PERFORMED. IN ATTEMPT TO STOP BLEEDING, A SHEATH (NOT FOR LEAD REMOVAL) WAS INSERTED INTO THE PUNCTURE SITE WITHOUT SUCCESS. THE BLEEDING SITE WAS BELIEVED TO BE SOMEWHERE IN THE SUBCLAVIAN VEIN, NOT THE PUNCTURE SITE; THEREFORE A WIRE GUIDE WAS EMPLOYED FROM THE RIGHT FEMORAL TO THE SUBCLAVIAN VEIN. THE BALLOON WAS THEN INFLATED IN AN EFFORT TO TRY TO STOP THE BLEEDING, BUT FAILED. THE USER CALLED PLASTIC AND VASCULAR SURGEONS WHICH WERE ABLE TO STOP THE BLEEDING. IT WAS ESTIMATED THAT THE DAMAGE TO THE SUBCLAVIAN VEIN WAS LESS THAN 10CM FROM THE PUNCTURE SITE. ADDITIONAL INFORMATION RECEIVED HAS INDICATED THAT THE PATIENT DIED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920933 LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23748 N173496 00827002237483

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death