BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSJUGULAR INTRAHEPATIC ACCESS SET

    MDR report key: 543813 · Received September 16, 2004

    Report

    Report Number
    1820334-2004-00558
    Event Type
    Injury
    Date Received
    September 16, 2004
    Date of Event
    August 19, 2004
    Report Date
    August 20, 2004
    Manufacturer
    COOK INCORPORATED
    Product Code
    GBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH HISTORY OF LIVER TUMORS. THIS PT HAD THREE PROCEDURES OF CHEMO-OBLATION OF THE LIVER AND ALSO HAS HAD RADIATION THERAPY. PT HAD A HEPATIC VENOGRAM PRIOR THAT SHOWED PATENT UPPER AND MIDDLE HEPATIC VEINS. THE SVC WAS NORMAL. THIS DIAGNOSTIC PROCEDURE WAS DONE WITH ACCESS THROUGH THE RIGHT INTERNAL JUGULAR VEIN. THE PT WAS LATER ADMITTED TO THE HOSPITAL WITH PORTAL HYPERTENSION AND IT WAS DECIDED TO DO A TIPS PROCEDURE DUE TO BLEEDING GASTRIC VARACIES AND THIS WAS AT THE END OF THE SAME WEEK. SINCE THE ANATOMY WAS NORMAL THEY PROCEEDED WITH THE INTERVENTION. UPON ACCESS OF THE RIGHT JUGULAR VEIN IT WAS FOUND TO BE DIFFICULT TO PASS THE CATHETER TO ORIGIN OF THE HEPATIC VEIN. A SUPERIOR VENACAVA GRAM REVEALED A TIGHT STENOSIS/SPASM OF THE SVC PROXIMAL TO THE RIGHT ATRIAL JUNCTION. FURTHER EVALUATION FOUND A SHARPLY TORTUOUS HEPATIC VEIN BUT THEY DECIDED TO PROCEED WITH THE TIPS PROCEDURE. AFTER MUCH MANIPULATION THE DILATOR AND 10 FRENCH SHEATH OF THE TJC-201-COPE SET WAS ADVANCED TO THE HEPATIC VEIN. THE DILATOR WAS THEN WITHDRAWN AND THE 10.0 FRENCH TFE CATHETER WAS PUT IN PLACE OF THE DILATOR. THE ROSS MODIFIED NEEDLE WAS THEN PLACED THROUGH THE CATHETER AND TORQUE ANTERIOLY. THIS WAS REPEATED SEVERAL TIMES AND THEN IT WAS NOTED THAT THE ROSS NEEDLE WAS STUCK IN THE SHEATH. THE ROSS NEEDLE WAS WITHDRAWN AND CONTRAST WAS INJECTED INTO THE SHEATH AND THIS REVEALED A TEAR IN THE SHEATH. AS THE SHEATH WAS BEING WITHDRAWN (TO BE REPLACED WITH ANOTHER SHEATH) THE END OF THE SHEATH (APPROXIMATELY 7 CENTIMETERS) BROKE OFF OF THE SHEATH AT THE PUNCTURE SITE IN THE RIJV. THE END OF THE SHEATH WAS WITHIN THE JUGULAR VEIN AND NOT ABLE TO BE REACHED FROM THE NECK. A VASCULAR SURGEON WAS CONSULTED AND IT WAS DECIDED TO RETRIEVE THE FRAGMENT OF SHEATH FROM A RIGHT FEMORAL VEIN APPROACH. THIS WAS PERFORMED BY THE SAME INTERVENTIONAL RADIOLOGIST THAT WAS DOING THE TIPS PROCEDURE. THE FRAGMENT RETRIEVAL WAS ACCOMPLISHED WITHOUT INCIDENCE AND THE PROCEDURE ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSJUGULAR INTRAHEPATIC ACCESS SET SPECIAL SET GBZ COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention