BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL STANDARD PORT

    MDR report key: 910929 · Received September 12, 2007

    Report

    Report Number
    6000126-2007-00102
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 10, 2007
    Report Date
    August 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    PMA / PMN Number
    K903364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RETURNED TO THE MANUFACTURER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY REPORT REVEALED THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SIMILAR COMPLAINT TREND REVIEW INDICATES THAT THERE HAVE BEEN NO PREVIOUS COMPLAINTS REPORTED FOR LOT NUMBER 1173920 ON THIS PARTICULAR FAILURE MODE. THE JULY 2007 15-MONTH STANDARD PORT NON VALVED PRODUCT FAMILY TREND REPORTS FOR THIS FAILURE MODE WAS REVIEWED AND NOTED NO ADVERSE TREND AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    ON AUGUST 13, 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A VAXCEL STANDARD PORT WAS PLACED FOR THERAPEUTIC PURPOSES INA PATIENT (AGE AND GENDER UNKNOWN). DURING THE PROCEDURE, THE PEEL AWAY SHEATH DID NOT PEEL PROPERLY AND ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL STANDARD PORT LJT BOSTON SCIENTIFIC M001453400 1173920

    Patients

    Seq Age Sex Outcome Treatment
    1 YR