BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PICC

    MDR report key: 912530 · Received September 13, 2007

    Report

    Report Number
    6000125-2007-00103
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    May 24, 2007
    Report Date
    August 10, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED AND EVALUATED BY THE MANUFACTURER. AS RECEIVED, A TEAR MEASURING APPROXIMATELY 0.055" IN LENGTH WAS LOCATED ON THE LEFT/WHITE SIDE OF THE LUMEN WALL, DISTAL TO THE SUTURE WING. THIS TEAR STARTED ON THE PARTING LINE OF THE SUTURE WING, APPROXIMATELY .025" JUST DISTAL TO THE SUTURE WING AND CONTINUED TO APPROXIMATELY .040", BUT DID NOT MEET THE INTERSECTION OF THE LUMEN INNER WALL. AN EXCESSIVE AMOUNT OF ADHESIVE SUBSTANCE WAS ALSO NOTICED ALL OVER THE OVER SLEEVES AND EXTENSION TUBES. NO OTHER MOLDING DEFECTS, SUCH AS PINCH MARKS, WERE NOTICED. BASED UPON THE EXAMINATION OF THE DEVICE, THE MOST PROBABLE ROOT CAUSE IS THE CATHETER TUBING BEING EXCESSIVELY STRESSED, FLEXED OR STRETCHED. A REVIEW OF THE DEVICE HISTORY REPORT WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE. THE REPORT CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SIMILAR COMPLAINT TREND REVIEW WAS PERFORMED AND FOUND ONE OTHER COMPLAINT AGAINST LOT NUMBER 1192747 BY A DIFFERENT CUSTOMER FOR A SIMILAR DEFECT. THE JULY 2007 15-MONTH PICCS VALVED TREND REPORT WAS REVIEWED AND NO ADVERSE TRENDS WERE DETECTED FOR "FRACTURE DISTAL TO THE SUTURE WING," "HOLE IN CATHETER" OR "LEAKAGE" FOR THE LAST 15 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A VAXCEL PICC KIT WHICH WAS IMPLANTED FOR THERAPEUTIC PURPOSES IN 2007 IN A PATIENT DEVELOPED A LEAK AT THE JUNCTION OF THE LINE AND THE SUTURE WING APPROXIMATELY FIVE WEEKS AFTER PLACEMENT. ON APPROX THREE MONTHS LATER, FOLLOW UP INFORMATION CONFIRMED THAT THE LEAK WAS DISTAL TO THE SUTURE WING. THE PICC WAS REMOVED APPROX FIVE WEEKS AFTER THE ORIGINAL DATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PICC KIT. THERE WERE NO COMPLICATIONS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PICC LJS BOSTON SCIENTIFIC M001455980 1192747

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR