BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT

    MDR report key: 88239 · Received February 1, 1995

    Report

    Report Number
    88239
    Event Type
    Injury
    Date Received
    February 1, 1995
    Date of Event
    September 14, 1994
    Report Date
    October 20, 1994
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE MONTHS AFTER THE IMPLANT OF A VASCULAR ACCESS PORT (VAD), THE PT COMPLAINED OF DISCOMFORT AROUND THE ACCESS PORT SITE. A CONTRAST STUDY WAS OBTAINED SHOWING THE CATHETER WAS FRACTURED APPROX 3CM IN LENGTH OF THE CENTRAL LINE AT THE JUNCTION OF THE CLAVILAND FIRST RIB, AND IT WAS FELT THAT THE DISTAL FRAGMENT WAS HELD IN PLACE BY A FIBRIN SHEATH. IT WAS FELT THAT AN ATTEMPT MUST BE MADE TO REMOVE THE CATHETER. IN SURGERY, AN ATTEMPT TO REMOVE THE CATHETER RESULTED IN THE DISTAL TIP SEPARATING AND REMAINED IN THE VENOUS SYSTEM. AFTER RECOVERY FROM ANESTHESIA, THE PT AGREED TO AN ATTEMPT FOR REMOVAL WITH INTERVENTIONAL RADIOLOGY. IN RADIOLOGY, THE LEFT FEMORAL VEIN WAS ENTERED VIA A SHEATH, WITH A SNARE CATHETER. AFTER MULTIPLE ATTEMPTS, THE FRACTURED CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT Implant VASCULAR ACCESS SYSTEM LJT COOK PACEMAKER CORP. 9112 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization D-5W/NS W/10M EQ KCL & 500MG MGS04| PLATINUM 115MG IN 1000CC NS W/30GMS MANNITOL