BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER

    MDR report key: 2522364 · Received March 30, 2012

    Report

    Report Number
    2032228-2012-00003
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 30, 2012
    Manufacturer
    AVALON LABORATORIES, LLC.
    Product Code
    DWF
    PMA / PMN Number
    081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT REPORT PROBLEM WITH CANNULA FUNCTIONALITY. CANNULA WAS LEFT IN AND UTILIZED FOR ADDITIONAL TREATMENT. PERFORATION AND ASSOCIATED PERICARDIAL EFFUSION IS A KNOWN COMPLICATION ASSOCIATED ECMO THERAPY PARTICULARLY IN SICK INFANTS WHERE TISSUE IS FRIABLE. THE REPORTED RATE OF PERFORATION HAS REMAINED CONSISTENTLY LOW (LESS THAN 0.04%). THE ECMO PROCEDURE FOR WHICH THIS CATHETER IS USED IS A LIFESAVING PROCEDURE FOR THE SICKEST OF INFANTS. THEREFORE, THE INHERENT RISK ASSOCIATED WITH CATHETER PLACEMENT IN THESE PTS IS OUTWEIGHED BY THE BENEFITS OF THE TREATMENT.

    Description of Event or Problem · 1

    PT WAS PLACED ON ECMO (B)(6) 2012, FOR RESPIRATORY FAILURE. CANNULA WAS PLACED WITH FLUOROSCOPY UTILIZING A SELDINGER TECHNIQUE. WITHIN 4 HRS PT'S O2 SATURATIONS WERE VERY LOW AND ON ECHO THE TIP OF THE CANNULA WAS FOUND TO HAVE MIGRATED INTO THE HEPATIC VEIN. CANNULA WAS REPOSITIONED WITH FLUORO INTO THE IVC. PT WAS STABLE UNTIL DAY 6 WHEN HE DEVELOPED TAMPONADE FROM A PERICARDIAL EFFUSION WITH BRADYCARDIA AND HYPOTENSION. PT WAS RESUSCITATED. TEN HOURS LATER A PERICARDIAL TUBE WAS PLACED TO DRAIN BLOOD WITH IMMEDIATE IMPROVEMENT. APPROXIMATELY 24 HRS LATER ECHO SHOWED NO RE-ACCUMULATION OF FLUID. HOWEVER, AN HR AFTER ECHO PT DEVELOPED TAMPONADE AND AGAIN REQUIRED RESUSCITATION AND DRAINAGE VIA THE PERICARDIAL TUBE. FIFTEEN MINUTES LATER HE REQUIRED CPR AND PERICARDIAL TUBE WAS FOUND CLOTTED. IT WAS REMOVED AND REPLACED ALLOWING ADDITIONAL DRAINAGE WHICH TURNED BRIGHT RED. PT WAS TAKEN TO SURGERY WHERE DIAPHRAGMATIC ARTERY WAS FOUND TO BE BLEEDING WHICH WAS FELT TO BE DUE TO THE REPLACEMENT OF THE PERICARDIAL TUBE. THIS WAS REPAIRED. THE PERICARDIUM WAS REPORTED TO LOOK "WEEPY" BUT NO IDENTIFIABLE SOURCE OF BLEEDING COULD BE IDENTIFIED. HEMOSTATIC AGENTS WERE APPLIED TO THE SURFACE OF THE HEART. THE PT WAS RETURNED TO ICU ON ECMO AND REMAINED STABLE. THE FOLLOWING DAY THE PT WAS SUCCESSFULLY WEANED FROM ECMO SUPPORT AND WAS DE-CANNULATED. HE HAS CONTINUED TO IMPROVE FROM HIS RESPIRATORY FAILURE AND ULTIMATELY WAS DISCHARGED FROM THE HOSP. REPORT FORM STATED THE EFFUSION WAS CAUSED BY THE BI-CAVAL CANNULA. ON F/U CUSTOMER STATED THE EFFUSION WAS ASSOCIATED WITH THE CANNULA BUT THEY COULD NOT IDENTIFY A SPECIFIC DEFECT OR FEATURE THAT WAS THE CAUSE OF THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER DWF AVALON LABORATORIES, LLC. 16 FR BI-CAVAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention