BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZURPAZ 8.5F STEERAB;E SHEATH

    MDR report key: 3801678 · Received April 25, 2014

    Report

    Report Number
    3004193842-2014-00001
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CREGANNA TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K131079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS MANIPULATING THE ZURPAZ SHEATH IN THE LEFT ATRIUM (WITH A BIOSENSE WEBSTER SF CATHETER THROUGH THE SHEATH). WHEN HE WAS MANOEUVRING THE SHEATH TO THE RIGHT SUPERIOR PULMONARY VEIN, HE NOTICED A PERICARDIAL EFFUSION. HE SENT FOR ECHO THE TECH CONFIRMED THE PERICARDIAL EFFUSION. THE CASE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250378 ZURPAZ 8.5F STEERAB;E SHEATH INTRODUCER, CATHETER DYB DYB CREGANNA TACTX MEDICAL ZURPAZ DS11829

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention