BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13 FR ELITE BI-CAVAL DUAL LUMEN CATHETER

    MDR report key: 1654623 · Received April 5, 2010

    Report

    Report Number
    2032228-2010-00002
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    November 1, 2009
    Report Date
    March 3, 2010
    Manufacturer
    AVALON LABORATORIES LLC.
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: RETAINS FROM LOTS 2133479, 2135040, 2134725 WERE REVIEWED AND THERE DID NOT APPEAR TO BE ANY ISSUE WITH THE INTRODUCER OR CANNULA (SHARP EDGES OR GAPS BETWEEN THE INTRODUCER AND TIP OF CANNULA). THE RETAIN SAMPLE WAS WITHIN SPECIFICATION. IT IS APPARENT FROM THE REPORT THAT THE DAMAGE TO THE HEART OCCURRED AS A RESULT OF THE INITIAL INSERTION OF THE CANNULA OR THE POSSIBLE POSITIONING OF THE CANNULA. THE IFU WARNS THAT INCORRECT INSERTION CAN CAUSE DAMAGE TO THE VESSELS AND OR HEART STRUCTURES. IN ADDITION THERE IS A CAUTION FOR VERIFICATION OF ADVANCEMENT, PLACEMENT AND POSITIONING OF THE CATHETER WITH THE INTRODUCER USING APPROPRIATE IMAGING TECHNOLOGY.

    Description of Event or Problem · 1

    A 13 FR ELITE BI-CAVAL CATHETER WAS PLACED INTO THE JUGULAR VEIN. THE CANNULA WAS POSITIONED USING THE INTRODUCER AND A GUIDE WIRE WITH VERIFICATION OF POSITION USING ECHO CARDIOGRAM. THE SURGEON REPORTED IT WAS DIFFICULT TO SEE THE CANNULA POSITION. TWO HOURS LATER, THE PT HAD SURGERY TO REPAIR A PERFORATION IN THE ATRIUM. THE PT CONTINUED USE OF THE CATHETER FOR 6 DAYS BEFORE THE CANNULA WAS REMOVED. THE PT WAS IN GOOD CONDITION AND RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 13 FR ELITE BI-CAVAL DUAL LUMEN CATHETER BI-CAVAL DWF AVALON LABORATORIES LLC. NA 091045223556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention