BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST / XCELA

    MDR report key: 2011663 · Received March 3, 2011

    Report

    Report Number
    1317056-2011-00020
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K091261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR THE REPORTED PART NUMBER IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(6) 2010 NAVILST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF XCELA PASV PICC AND THE FAILURE MODE OF "USER ERROR." NO ADVERSE TRENDS WERE IDENTIFIED. THE RISK MANAGEMENT DEPARTMENT AT THE END USER HOSPITAL HAS MOST RECENTLY STATED THAT THE EVENT WAS CAUSED BY NURSING ERROR. THERE IS NO INDICATION THAT THIS INCIDENT IS THE RESULT OF A NAVILYST MEDICAL MANUFACTURING OR DESIGN ISSUE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, A FEMALE, (B)(6), PRESENTED AT THE EMERGENCY ROOM WITH A WIRE COMING FROM HER MOUTH WHICH WAS REMOVED WITHOUT ANY COMPLICATIONS. THE HOSPITAL LOOKED INTO THE PT HISTORY AND PROVIDED THE FOLLOWING INFORMATION: THE PT FIRST REC'D A NAVILYST 5F XCELA PICC DEVICE ON (B)(6) 2010, PLACED IN THE RIGHT ARM. THAT PICC WAS REMOVED ON (B)(6) 2010 BECAUSE IT WOULD NO LONGER FLUSH AND A NEW 5F XCELA PICC WAS PLACED IN THE LEFT ARM. X-RAY INDICATED THE PICC WAS TOO SHORT SO THAT PICC WAS EXCHANGED FOR A NEW 5F XCELA PICC. ON (B)(6) 2010 IT WAS NOTED THE PICC WOULD NOT FLUSH. AN X-RAY WAS ORDERED AND THE PICC WAS RECOILED IN THE SUBCLAVIAN. THE PICC WAS ADJUSTED AND THE SECOND CHEST X-RAY SHOWED THE PICC UP THE IJ. THE PICC WAS ADJUSTED AGAIN AND THE THIRD CHEST X-RAY SHOWED THE PICC IN THE SVC. PRESENCE OF THE WIRE WAS NEVER DETECTED BY A RADIOLOGIST, HOWEVER, WHAT LOOKS LIKE A WIRE IS SLIGHTLY VISIBLE IN SOME LATER X-RAYS IN THE SVC TO RIGHT IJ. ON (B)(6) 2011 THE PT CAME INTO THE ER TO HAVE THE WIRE REMOVED FROM HER MOUTH. THE PHYSICIAN GAVE THE WIRE TO THE PT. THE HOSPITAL CONTACTED THE PT LATER TO SEE IF THEY COULD GET THE WIRE BUT THE PT SAID SHE COULD NOT GIVE IT BACK TO THE HOSPITAL. IT IS UNK IF SHE STILL HAS A WIRE OR NOT. NOBODY AT THE HOSPITAL CAN CONFIRM IF THE WIRE WAS A VASCULAR WIRE USED TO PLACE PICC OR A WIRE FROM SOME OTHER SOURCE. THE PT DID NOT COMPLAIN OF ANY PAIN OR SYMPTOMS. THE PT CONDITION IS FINE. THE PT HAS NOT CONTACTED THE HOSPITAL ABOUT ANYTHING INCLUDING THE HOSPITAL'S REQUEST TO GET THE WIRE BACK. THE HOSPITAL IS NOT AWARE OF ANY OTHER PROCEDURES THE PT HAD THAT MIGHT HAVE LEFT THE WIRE BEHIND. THEY NOTED THE WIRE APPEARED PRESENT IN SOME CHEST X-RAYS BUT APPEARED TO MOVE (PROBABLY DUE TO THE ANGLE OF THE X-RAY) MAKING IT HARD TO DETERMINE IF THE WIRE WAS IN THE SVC OR THE ESOPHAGUS. BASED ON THE REVIEW OF THE X-RAYS REVIEWED BY TWO PICC NURSES, THE WIRE APPEARED TO BE APPROX 20 CM LONG. THE CLINICIAN WHO REMOVED THE WIRE INDICATED THAT THE NON-FLOPPY END PRESENTED IN THE PT'S MOUTH. ADDITIONAL INFORMATION HAS BEEN OBTAINED ON (B)(6), 2011 - PER (B)(6), THEIR RISK MANAGEMENT DEPT HAS MADE THE DETERMINATION THAT THIS EVENT IS THE RESULT OF NURSING ERROR. AN ER DOCTOR HAS CONFIRMED THAT THE GUIDEWIRE WAS A 60CM VASCULAR WIRE THAT HAD BEEN LEFT IN THE CATHETER DURING THE PICC EXCHANGE. THE DOCTOR FURTHER STATED THAT THE WIRE WAS ACTUALLY REMOVED FROM ONE OF THE VESSELS IN THE PT'S TONGUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST / XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention