BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION SHORTIE DILATOR SHEATH

    MDR report key: 19514657 · Received June 10, 2024

    Report

    Report Number
    MW5156157
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    January 9, 2024
    Report Date
    May 30, 2024
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A COOK MEDICAL EVOLUTION SHORTIE DILATOR SHEATH WAS USED TO REMOVE A TARGETED RIGHT VENTRICULAR (RV) LEAD WHEN ADJACENT LEAD DAMAGE OCCURRED ON A RIGHT ATRIAL (RA) LEAD, REQUIRING IT TO BE REPLACED (THE RA LEAD WAS NOT ORIGINALLY TARGETED FOR REMOVAL). ALTHOUGH A (B)(6) GLIDELIGHT LASER SHEATH WAS IN USE DURING THE PROCEDURE AS WELL, THE PHYSICIAN STATED IT WAS THE COOK SHORTIE WHICH CUT THE NON-TARGETED RA LEAD, REQUIRING INTERVENTION TO REPLACE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION SHORTIE DILATOR SHEATH. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. 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
    803157 EVOLUTION SHORTIE DILATOR SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown (B)(6) GLIDELIGHT LASER SHEATH.| RIGHT ATRIAL LEAD.