BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BI-DIRECTIONAL CASH., 7F, MEDIUM CURL, 4MM

    MDR report key: 3003983 · Received November 13, 2008

    Report

    Report Number
    2182269-2008-00261
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P960916/S0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN AVRT CASE, A SAFIRE CATHETER WAS PLACED RETROGRADE UP THE AORTA AND INTO THE LEFT ATRIUM. THERE WAS A ST SEGMENT DEPRESSION AND THE PATIENT'S BLOOD PRESSURE DROPPED. AN ECHO WAS PERFORMED WHICH REVEALED THE PATIENT HAS TAMPONADE. THE CASE WAS ENDED AND A PERICARDIAL TAP WAS PERFORMED. THE PATIENT WAS TAKEN TO CCU AND WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE SAFIRE CATHETER WAS THE ONLY PRODUCT IN THE LEFT ATRIUM. THE PHYSICIAN DOES NOT BLAME THE SAFIRE CATHETER FOR THE PERFORATION BUT FEELS THAT THE PATIENT'S ATRIAL WALL WAS THIN AND THE CATHETER BURNED THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BI-DIRECTIONAL CASH., 7F, MEDIUM CURL, 4MM SAFIRE CATHETER, 7F, MED OAD ST. JUDE MEDICAL NA 2003908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other