BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL / NAVILYST MEDICAL

    MDR report key: 4895914 · Received July 2, 2015

    Report

    Report Number
    1317056-2015-00133
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO LOT NUMBER WAS PROVIDED BY THE HOSPITAL, FROM THE SERIAL NUMBER, IT COULD BE DETERMINED THAT THE MANUFACTURING/PACKAGING RECORDS OF THE PORT WOULD DATE BACK TO 2007. THE EXACT PACKAGING LOT#/DATE IS UNKNOWN. THE NAVILYST MEDICAL (B)(6) 2015 COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY VAXCEL PASV PORT, AND THE FAILURE MODE "CATHETER FRACTURED/MIGRATED." NO ADVERSE TREND WAS IDENTIFIED AND NO SIMILAR COMPLAINT HAS BEEN REPORTED IN THE PAST 15 MONTHS. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. NO DHR REVIEW WAS CONDUCTED SINCE THERE WAS NO REPORTED ITEM OR LOT NUMBER. THE PORT ASSEMBLY AND CATHETER TUBING FUNCTIONED CORRECTLY DURING TREATMENT USE SINCE 2008 (~7YEARS) AND ISSUE OF CATHETER TUBING FRACTURE OCCURRED DURING PORT REMOVAL. PATIENT ANATOMY AND VASCULAR DEBRIS MAY HAVE CONTRIBUTED TO THE RESISTANCE OF THE CATHETER TUBING DURING REMOVAL. IN ADDITION, SOME DEGREE OF "PINCH-OFF" SYNDROME MAY HAVE CONTRIBUTED TO A WEAKENED AREA OF THE CATHETER TUBING. THE DIRECTIONS FOR USE SUPPLIED WITH THE DEVICE INSTRUCTS THE PHYSICIAN/CLINICIAN ON HOW TO PROPERLY IMPLANT THE CATHETER/PORT, AND CAUTIONS AGAINST CERTAIN HANDLING TECHNIQUES TO AVOID "PINCH-OFF" SYNDROME. MANUFACTURING PROCESS CONTROLS FOR THIS DEVICE INCLUDE 100% LEAK TESTING AS WELL AS 100% TESTING FOR PROPER FUNCTIONING OF THE VALVE. ADDITIONAL QUALITY INSPECTIONS OF THE CATHETER INCLUDE VISUAL INSPECTIONS FOR KINKS OR DAMAGE, DIMENSIONAL VERIFICATION, INSPECTION WITH A GUIDEWIRE FOR LUMEN OCCLUSIONS, AND VERIFICATION OF THE MOLECULAR WEIGHT OF THE TUBING.

    Description of Event or Problem · 1

    AS REPORTED: "VENOUS PORT IMPLANTED BY ANOTHER FACILITY IN 2008, SCHEDULED FOR REMOVAL (B)(6) 2015. DURING THE REMOVAL ATTEMPT, THE CATHETER OF THE PORT MET WITH RESISTANCE AND BROKE DURING THE EXPLANATION. NUMBER STAMPED ON THE BACK OF THE PORT: (B)(4). PATIENT SENT FOR A CSR TO VERIFY LOCATION OF THE REMAINING CATHETER. FOLLOWING THE ID OF THE CATHETER, THE PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY PROCEDURE IN AN ATTEMPT TO SNARE THE REMAINING CATHETER AND REMOVE IT, WHICH WAS NOT SUCCESSFUL, AND THE CATHETER REMAINS IN THE PATIENT." FOLLOW-UP WITH THE REPORTING HOSPITAL INDICATES THAT THE PATIENT WAS DISCHARGED FOLLOWING THE UNSUCCESSFUL ATTEMPT TO RETRIEVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431234 VAXCEL / NAVILYST MEDICAL PORT, INTERNAL, SUBCUTANEOUS LJT NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention