BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH

    MDR report key: 18713149 · Received February 14, 2024

    Report

    Report Number
    MW5151710
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Report Date
    January 18, 2024
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DURING A LEFT ATRIUM APPENDAGE CLOSURE. THE PROCEDURE WAS ABORTED. A DECISION WAS MADE TO USE A COOK SHEATH IN GROIN TO ATTEMPT TO INTRODUCE AN IC CATHETER ON THE LEFT SIDED IT DID NOT WORK. 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
    450545 SHEATH INTRODUCER, CATHETER DYB COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown