BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET

    MDR report key: 7651625 · Received June 29, 2018

    Report

    Report Number
    7651625
    Event Type
    Death
    Date Received
    June 29, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 29, 2018
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED INSERTION OF LEFT INTERNAL JUGULAR VEIN TUNNELED CENTRAL VENOUS CATHETER, COMPLICATED BY SUSPECTED RIGHT HEMOTHORAX. PROGRESSION TO HEMORRHAGIC SHOCK AND CARDIAC ARREST FOLLOWING INITIATION OF ACLS AND PLACEMENT OF TWO RIGHT CHEST TUBES. RETURN OF SPONTANEOUS CIRCULATION (ROSC) ACHIEVED BEFORE SECOND EVENT OF CARDIAC ARREST, OF WHICH PATIENT WAS UNABLE TO BE RESUSCITATED. CONCERN REGARDING DESIGN OF DEVICE AS ATTRIBUTING TO THE PUNCTURE OF THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493385 GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET CATHETER, HEMODIALYSIS, IMPLANTED MSD BARD ACCESS SYSTEMS, INC. 5393230 REBV0174

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Death