BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONVOY SHEATH

    MDR report key: 587053 · Received April 1, 2005

    Report

    Report Number
    2939222-2005-00009
    Event Type
    Death
    Date Received
    April 1, 2005
    Date of Event
    March 25, 2005
    Report Date
    March 31, 2005
    Manufacturer
    EP TECHNOLOGY BBC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR PLACED TWO CONVOY SHEATHS IN PATIENT. BOTH SHEATHS WERE POSITIONED IN THE LEFT ATRIUM. CONSTELLATION CATHETER AND RPM ABLATION CATHETER WERE INSERTED THROUGH SHEATHS. AFTER ISOLATION OF THE PULMONARY VEINS, THE SHEATHS WERE PULLED BACK INTO THE RIGHT ARTIUM. THE CONVOY SHEATH WAS PLACED IN THE SVC AND CONSTELLATION CATHETER WAS POSITIONED IN THE SVC. AFTER SVC WAS ISOLATED CONSTELLATION CATHETER WAS REMOVED AND CONVEYS WAS PULLED BACK TO THE IVC. THE PATIENT HAD MANY MAJOR MOVEMENTS AND THE SHEATH APPARENTLY ADVANCED THROUGH THE RVOT AND INTO THE PULMONARY ARTERY WITH ACCELERATIONS AND PERFORATION CAUSING PERICARDIAL AND LEFT PLEURAL BLEEDING. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVOY SHEATH SHEATHS DYB EP TECHNOLOGY BBC M0045676ST0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death M004 5670ST 0 CONVOY SHEATH M004 US8031 0| CONSTELLATION-UNCOATED