BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL SHEATH

    MDR report key: 17531589 · Received August 12, 2023

    Report

    Report Number
    MW5138502
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    April 13, 2017
    Report Date
    May 4, 2017
    Manufacturer
    ABBOTT; KALILA MEDICAL
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN AFIB PROCEDURE THE PATIENT WAS TAKEN TO POST OP/RECOVERY WHERE IT WAS NOTICED WHILE EXTUBATING THE PATIENT THAT THE PRESSURE WAS DROPPING. THE PRESSURE STAYED LOW SO AN ECHO WAS ORDERED. AN ANTERIOR EFFUSION WAS NOTED ON THE ECHO. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND THE PATIENT IS IN STABLE CONDITION AT THE TIME OF THE CALL. THE CALLER STATES THAT THE PHYSICIAN THINKS THAT THE EFFUSION WAS CAUSED BY THE ABBOTT KALILA SHEATH. THE PATIENT WILL STAY IN THE ICU OVERNIGHT FOR OBSERVATION. THE SUSPECTED DEVICE IS THE ABBOTT/KALILA MEDICAL TRANSSEPTAL SHEATH. (B)(4). 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
    1073012 TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB ABBOTT; KALILA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown