BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT IMPLANTABLE VASCULAR ACCESS SYSTEM

    MDR report key: 11350 · Received February 7, 1994

    Report

    Report Number
    MW1000654
    Event Type
    Injury
    Date Received
    February 7, 1994
    Date of Event
    January 12, 1994
    Report Date
    January 20, 1994
    Manufacturer
    STRATO MEDICAL CORP.
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EXTRAVASATION OF INTRAVENOUS FLUID REQUIRING REMOVAL OF SHUNT. INJECTION OF CONTRAST DYE UNDER FLUOROSCOPY SHOWED EXTRAVASATION ALONG COURSE OF CATHETER AND INTO SOFT TISSUE AT JUNCTION OF CATHETER TO PORT. THE PRECEEDING DAY RPTR WAS ABLE TO ASPIRATE BLOOD BEFORE GIVING ADRIAMYCIN, VINBLASTINE PLATINUM CHEMOTHERAPY. UNABLE TO ASPIRATE AFTER EXTRAVASATION NOTED. REMOVED CATHETER SHOWED 2 LINEAR SLITS APPROX 1 CM LONG (PARALLEL) AT MID PORTION OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT IMPLANTABLE VASCULAR ACCESS SYSTEM Implant LJT STRATO MEDICAL CORP. LPS 7513

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R