BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTI +

    MDR report key: 2834129 · Received October 10, 2012

    Report

    Report Number
    2834129
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 9, 2012
    Manufacturer
    CORDIS (JOHNSON & JOHNSON)
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN THE EP LAB FOR ABLATION. AT THE BEGINNING OF THE PROCEDURE ONE OF THE SHEATHS BROKE AND PART OF IT WAS LEFT INTRAVENOUSLY. A CV SURGEON REMOVED THE BROKEN SEGMENT. THE ABLATION PROCEDURE WAS ABORTED AND THE PT WAS SUCCESSFULLY EXTUBATED. HOWEVER, PRIOR TO THE PT BEING TRANSFERRED OUT TO THE EP LAB, SHE DEVELOPED SEVERE BRADYCARDIA AND THEN PEA. SHE WAS RESUSCITATED, INTUBATED AND ADMITTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTI + SHEATH INTRODUCER DYB CORDIS (JOHNSON & JOHNSON) 6F MS UNABLE TO DETERMINE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention