BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASV PORT

    MDR report key: 655899 · Received December 23, 2005

    Report

    Report Number
    6000126-2005-00337
    Event Type
    Injury
    Date Received
    December 23, 2005
    Date of Event
    November 21, 2002
    Report Date
    November 23, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PASV PORT WAS PLACED FOR THERAPEUTIC PURPOSES IN 2002. UPON COMPLETION OF THE PT'S SECOND CHEMOTHERAPY TREATMENT ABOUT 3 WEEKS LATER, AN ORANGE-CLEAR LIQUID WAS OBSERVED ON THE SKIN AT THE SITE OF THE PORT. THE LIQUID WAS BELIEVED TO BE TAXOTERE, ONE OF THE TWO CHEMICALS IN THE PT'S CHEMOTHERAPY. THE LEAK OCCURRED AT 4:00 PM AND EMERGENCY SURGERY WAS PERFORMED AT 11:00 PM DUE TO THE PT CONSUMING FOOD DURING HER CHEMOTHERAPY AND THE NEED FOR GENERAL ANESTHESIA. IN SURGERY, THE DEVICE WAS REMOVED REVEALING AN OPENING IN THE TUBING WHERE THE TAXOTERE LEAKED. THE WOUND CREATED BY THE REMOVAL SURGERY LEFT A HOLE APPROXIMATELY 1-1/4 INCH IN DIAMETER, ABOUT 1/2 INCH DEEP WHICH WAS NOT CLOSED BUT LEFT OPEN TO HEAL FROM THE INSIDE OUT AND PACKED WITH STERILE GAUZE. FOR OVER TWO MONTHS AFTER THE REMOVAL SURGERY, THE PT WAS REQUIRED TO PACK THE SURGICAL HOLE WITH 36 INCHES OF GAUZE THREE TIMES DAILY. IN 2002, ANOTHER PORT WAS PLACED. SUBSEQUENT TO THE REMOVAL OF THE SURGERY, THE PT CONTINUED TO EXPERIENCE INTERMITTENT OR RECURRENT PAIN DEEP IN THE CHEST TOWARD HER SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASV PORT VASCULAR ACCESS SYSTEM LJT BOSTON SCIENTIFIC NA 10A0502228

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention