BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST / VAXCEL

    MDR report key: 2031512 · Received March 21, 2011

    Report

    Report Number
    1317056-2011-00028
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K991897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS 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)(4) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PORT AND THE FAILURE MODE OF "CATHETER FRACTURED." NO ADVERSE TRENDS WERE IDENTIFIED. THE PORT SAMPLE WAS RETURNED WITH THE COLLAR AND CATHETER TUBING STILL ATTACHED. A SLICE/FRACTURE WAS NOTED IN THE CATHETER TUBING APPROX 1 CM FROM THE PORT STEM, ON TOP OF THE CATHETER OPPOSITE A "SET" IN THE TUBING. THE FRACTURE IS CONSISTENT WITH DAMAGE DUE TO REPEATED FLEXING OF THE CATHETER. THE CATHETER ITSELF HAS A DISTINCT SET TO IT THAT INDICATES IT HAD BEEN IMPLANTED WITH THE CATHETER ENTERING THE TUNNELED REGION AT AN ANGLE. THE DIRECTIONS FOR USE PACKAGED WITH THIS DEVICE CONTAINS A STATEMENT "CAUTION SHOULD BE TAKEN TO AVOID ANGLES, WHICH COULD OCCLUDE THE CATHETER LUMEN. A TUNNEL WITH A GENTLE ARC REDUCES THE RISK OF KINKING." THERE IS NO EVIDENCE THAT EITHER THE PORT OR CATHETER IN QUESTION WERE DEFECTIVE AT TIME OF IMPLANT, NOR IS THERE EVIDENCE THAT DEFECT WAS A RESULT OF A MANUFACTURING OR DESIGN DEFICIENCY. THE END USER ATTACHES THE CATHETER TO THE PORT. BASED ON THE CONDITION OF THE PORT ASSEMBLY, THE CATHETER APPEARS TO HAVE BEEN ASSEMBLED PROPERLY ONTO THE PORT BY THE END USER. BASED ON EVALUATION OF THE RETURNED SAMPLE, A POSSIBLE ROOT CAUSE MAY BE REPEATED FLEXING OF THE CATHETER TUBING, HOWEVER, WE ARE UNABLE TO DEFINITIVELY DETERMINE AN EXACT ROOT CAUSE FOR THIS INCIDENT AT THIS TIME. THE CATHETER TUBING IS A PURCHASED COMPONENT FOR NAVILYST MEDICAL AND THE TUBING SUPPLIER, (B)(4), HAS BEEN MADE AWARE OF THIS REPORT. NAVILYST MEDICAL PROCESS CONTROLS FOR THE PORT DEVICE INCLUDE THE FOLLOWING: 100% AIR LEAK TESTING AND VERIFICATION OF CORRECT ASSEMBLY. THE INCOMING INSPECTION OF THE CATHETERS INCLUDE DIMENSIONAL MEASUREMENTS, STATIC BURST TESTING AND TENSILE TESTING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, DURING THE PROCEDURE TO REMOVE AN IMPLANTED 8F VALVED PORT BECAUSE OF REPORTED LEAKAGE, THE CATHETER WAS NOTED TO HAVE A SPLIT IN THE TUBING NEAR THE STEM OF THE PORT. THE CATHETER HAD BEEN IN LACE FOR APPROX 2 YEARS. THE PORT ASSEMBLY WAS REPLACED, AND NO PT COMPLICATIONS WERE REPORTED. THE USED DEVICE WAS RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST / VAXCEL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1354064

    Patients

    Seq Age Sex Outcome Treatment
    1