BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE SINUS CATHETER

    MDR report key: 1062613 · Received June 18, 2008

    Report

    Report Number
    6000002-2008-07618
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT - EP WAS FLUSHED PROPERLY TO ENDURE EFFICACY. CATHETER WAS INSERTED USING TEE (NO FLUOROSCOPY WAS USED). WHEN IT CAME TIME TO DELIVER RETROGRADE CARDIOPLEGIA, THE LINE PRESSURE WAS EXTREMELY HIGH AND CARDIOPLEGIA WOULD NOT PASS THROUGH THE LINE. TROUBLESHOOTING: THE LINE WAS FLUSHED SEVERAL TIMES AND SYRINGE PULLED BACK-ON TO SEE IF THERE WAS BLOCKAGE. ALSO, THE CATHETER WAS PULLED BACK IN CASE IT WAS TOO FAR INTO THE CORONARY SINUS. ANTEGRADE CARDIOPLEGIA WAS USED FOR THE ENTIRE CASE SINCE THE EP WASN'T WORKING. ONCE THE MITRAL VALVE WAS REPAIRED, THE HEART CLOSED AND FILLED BY PERFUSION. DR. SAW EXTREME BLEEDING FROM THE HEART. AFTER INVESTIGATING THE BLEEDING, HE DETERMINED THAT A VESSEL OFF THE CORONARY SINUS WAS PERFORATED. HE BELIEVES IT WAS PERFORATED BY THE EP. AFTER THE CASE, ANESTHESIOLOGIST TRIED FLUSHING THE CATHETER AND IT WOULD NOT FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE SINUS CATHETER SINUS CATHETER DWF EDWARDS LIFESCIENCES EP MS1107031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other