BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH 15 FR SHEATH

    MDR report key: 17537568 · Received August 12, 2023

    Report

    Report Number
    MW5144441
    Event Type
    Death
    Date Received
    August 12, 2023
    Date of Event
    January 14, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC
    Product Code
    DRA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ATH IS NOT MANUFACTURED OR IMPORTED BY BIOSENSE WEBSTER, INC. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING AN CRYE ATRIAL FIBRILLATION PROCEDURE, THE PATIENT WAS NOTED TO HAVE AN "PERICARDIA! EFFUSION" ON ICE. THE PHYSICIAN HAD ATTEMPTED TO "RE-CROSS DURING A CASE" WITH A MEDTRONIC SHEATH AND IN THAT PROCESS THE PATIENT EXPERIENCED LOW BLOOD PRESSURE VALUES. USING ICE, AN EFFUSION WAS NOTED IN THE LEFT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED WITH 700CC OF BLOOD/FLUID WITHDRAWN. AT THE TIME, THE PATIENT STABILIZED. AFTER STABILIZING THE PATIENT, THE PATIENT ENDED UP WITH FURTHER BLEEDING AND WENT TO THE OPERATING ROOM FOR SURGERY. DESPITE THE SURGERY AND FLUID REPLACEMENTS, THE PATIENT ULTIMATELY EXPIRED. THE ONLY BIOSENSE WEBSTER, INC. CATHETER IN USE (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
    1073390 FLEXCATH 15 FR SHEATH CATHETER, STEERABLE DRA MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown