BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORDIS

    MDR report key: 715403 · Received May 3, 2006

    Report

    Report Number
    MW1039012
    Event Type
    Other
    Date Received
    May 3, 2006
    Date of Event
    April 11, 2006
    Report Date
    May 3, 2006
    Manufacturer
    CORDIS CORP
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P ORTHOTOPIC HEART TRANSPLANT IN FOR ROUTINE RIGHT HEART CATH AND BIOPSY. CORDIS BIPAL 7 BIOPTOME INSERTED, JAWS OPENED, JAWS CLOSED, AND BIOPTOME REMOVED. UPON REMOVAL, IT WAS DISCOVERED THE JAWS OR "HEAD" REMAINED IN THE RIGHT VENTRICLE. ATTEMPTS WERE MADE TO SNARE THE PIECE WITHOUT SUCCESS. DECISION WAS MADE TO LEAVE THE PIECE, AS IF IT WERE A VENTRICULAR PACEMAKER LEAD TIP, ASSUMING IT WOULD ENDOTHELIALIZE OVER TIME. THE PT REMAINED STABLE THROUGHOUT PROCEDURE AND HAS SUFFERED NO SEQUALAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS BIPAL 7 KNW CORDIS CORP 502-402B N1108306

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other