BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13 FR ELITE BI-CAVAL DUAL LUMEN CATHETER

    MDR report key: 1622965 · Received March 2, 2010

    Report

    Report Number
    2032228-2010-00001
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 22, 2010
    Manufacturer
    AVALON LABORATORIES, LLC.
    Product Code
    DQO
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR FROM THE REPORT IF THE DAMAGE TO THE HEART OCCURRED AS A RESULT OF THE INITIAL INSERTION OF THE CANNULA OR THE POSSIBLE REPOSITIONING OF THE CANNULA AS A RESULT OF PT MOVEMENT. 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. EVALUATION SUMMARY: THE COMPLAINT UNIT WAS REVIEWED BY (B) (4) WITH (QUALITY DIRECTOR) AND (B) (4) (PRODUCT MGR) ON 02/23/10. A 13 FR ELITE BI-CAVAL CATHETER WAS RETURNED WITHOUT THE INTRODUCER. VISUAL INSPECTION SHOWED THAT THERE WAS NO SPRING DAMAGE OR OTHER DAMAGE TO THE PART. THE CATHETER WAS CHECKED FOR SHARP EDGES OR SHARP SURFACES AND NONE WERE FOUND. THE CENTRAL LUMEN WAS CHECKED FOR LEAKAGE AND WAS FOUND TO BE IN TACT. THERE DID NOT APPEAR TO BE ANY PART OF THE CANNULA CAPABLE OF PERFORATING THE HEART. THE INTRODUCER WAS NOT RETURNED WITH THE CANNULA BUT THE DEVICE HISTORY FILE WAS REVIEWED, AND THERE WERE NO NONCONFORMANCES WITH THE INTRODUCER USED IN THIS LOT. THE EVALUATED CATHETER WAS FOUND TO MEET SPECIFICATION AND NO DEFECTS WERE DETECTED.

    Description of Event or Problem · 1

    A 13 FR ELITE BI-CAVAL CATHETER WAS PLACED INTO THE JUGULAR VEIN. THE CANNULA WAS POSITIONED USING FLUOROSCOPY AND WAS LOCATED CORRECTLY. THE PRODUCT HAD GOOD FLOW. THE PT WAS ON THE CATHETER FOR 5 DAYS WHEN CARDIAC ARREST OCCURRED. AN ECHO CARDIOGRAM SHOWED FLUID IN THE PERICARDIUM. AN EFFUSION WAS DISCOVERED AND SURGICALLY REPAIRED. IT IS UNCLEAR IF MOVEMENT OF THE PT 2 DAYS BEFORE MAY HAVE CAUSED A CHANGE IN THE POSITION OF THE CATHETER AND REQUIRED REPOSITIONING. THE PT WAS GOING TO HAVE THE CANNULA REMOVED PRIOR TO THE CARDIAC ARREST BUT THE CATHETER WAS CONTINUED TO BE USED FOR SEVERAL ADDITIONAL DAYS POST SURGERY BEFORE IT WAS REMOVED AND RETURNED TO AVALON LABORATORIES. THE PT IS IN GOOD CONDITION AND BEING 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 DQO AVALON LABORATORIES, LLC. 090111416905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention