BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT VAXCEL

    MDR report key: 886360 · Received July 30, 2007

    Report

    Report Number
    6000126-2007-00079
    Event Type
    Injury
    Date Received
    July 30, 2007
    Date of Event
    June 25, 2007
    Report Date
    July 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    PMA / PMN Number
    K991897
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED BY THIS MANUFACTURER FOR EVALUATION; CONSEQUENTLY, A PHYSICAL EVALUATION HAS NOT YET BEEN PERFORMED. WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL ASSEMBLY AND PERFORMANCE SPECIFICATIONS. LOT 1100536 WAS PREVIOUSLY REPORTED FOR A SIMILAR INCIDENT. A REVIEW OF THE JUNE 2007 COMPLAINT REPORT FOR THE VAXCEL PASV PORT FAMILY NOTED THAT THERE WAS ONE COMPLAINT REPORTED AND ZERO COMPLAINTS REPORTED THE FOLLOWING MONTH AND ONE MONTH LATER, IN THE "CATHETER FRACTURED" FAILURE MODE. IT ALSO NOTED THAT THERE WAS ONE COMPLAINT REPORTED AND ZERO COMPLAINTS REPORTED THE "DEVICE BROKEN/MIGRATED" FAILURE MODE. THIS DOES NOT CONSTITUTE AN ADVERSE TREND. IN ADDITION THE JUNE 2007, 15 MONTH PORT VALVED COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURES MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIANS HAD SUCCESSFULLY IMPLANTED A VAXCEL PORT IN A FEMALE PT (AGE UNK) IN 2006. IN 2007, THE DATE OF THE PT'S LAST CHEMOTHERAPY TREATMENT, THE PT COMPLAINED THAT IT HURT WHEN THE INFUSION NURSE FLUSHED THE DEVICE. THE PT WAS GIVEN A CHEST X-RAY, AND IT WAS DETERMINED THAT A PORTION OF THE PORT CATHETER HAD BECOME DETACHED, LEAVING THREE INCHES OF THE CATHETER ATTACHED TO THE PORT. ANOTHER IMAGE REVEALED THAT THE DETACHED PORTION OF THE CATHETER HAD LODGED IN THE RIGHT VENTRICLE OF THE PT'S HEART. THE PT WAS TRANSPORTED TO THE CARDIAC CATH LAB OF A LOCAL HOSPITAL FOR RETRIEVAL BY A CARDIOLOGIST OF THE DETACHED CATHETER PIECE. THE COMPLAINANT REPORTED THAT THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PT'S CONDITION IS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT VAXCEL LJT BOSTON SCIENTIFIC NA 1100536

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R