BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 12474743 · Received September 15, 2021

    Report

    Report Number
    2522007-2021-00025
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    February 25, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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

    A RECENTLY PUBLISHED ARTICLE IDENTIFIED FOUR POSSIBLE ADVERSE EVENTS WITHIN SLOVENIA. THE ARTICLE DETAILED THAT JUS KSELA AND HIS COLLEAGUES PERFORMED 131 LEADS EXTRACTIONS FROM 2015 THROUGH 2019 AT THE UNIVERSITY MEDICAL CENTER LJUBLJANA. THE RETROSPECTIVE STUDY UTILIZED COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SETS DURING TRANSVENOUS LEAD EXTRACTIONS AND CONCLUDED THE STUDY WITH PROCEDURAL AND CLINICAL SUCCESS RATES OF 92.4% AND 98.5%, RESPECTIVELY. THE PHYSICIANS REPORTED 4 ADVERSE EVENTS OCCURRING INSIDE THE 67-PATIENT AGGREGATE. TWO PATIENTS HAD SUBCLAVIAN VEIN THROMBOSIS AND ARM SWELLING; TREATED WITH ANTICOAGULATION THERAPY FOR THREE MONTHS. THIS COMPLAINT IDENTIFIES ONE INDIVIDUAL WITH SUBCLAVIAN VEIN THROMBOSIS AND ARM SWELLING. THERE WERE NO PATIENT DEATHS IN THE COHORT; THE FOLLOWING COMPLAINTS ARE RELATED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372047 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention