BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 13534239 · Received February 15, 2022

    Report

    Report Number
    2522007-2022-00004
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 3, 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 · 0

    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 · 0

    THIS LITERATURE FINDING SPECIFIES A MAJOR ADVERSE EVENT IN TWO PATIENTS ATTRIBUTED TO THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DURING TRANSVENOUS LEAD EXTRACTIONS. THE TWO PATIENTS DEVELOPED CARDIAC TAMPONADE. A THORACOTOMY WAS PREFORMED WHERE SURGEONS PATCHED THE VENA CAVA SUPERIOR AND LEFT ATRIUM. ALL PATIENTS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734835 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention