BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET

    MDR report key: 1714345 · Received May 26, 2010

    Report

    Report Number
    1820334-2010-00252
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 28, 2010
    Manufacturer
    COOK, INC.
    Product Code
    GBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. EACH LARGE CHECK-FLO INTRODUCER SET IS INSPECTED 100% TO CONFIRM CORRECT PLACEMENT OF MARKER BAND AND THE MARKER BAND MUST BE COMPLETELY COVERED BY MATERIAL. NOTE: MARKER IS BONDED BETWEEN TUBINGS AND MUST NOT PROTRUDE THROUGH TUBING. BASED ON REPORTED STATEMENTS OF THE EVENT, THE ROOT CAUSE OF THIS FAILURE MODE HAS BEEN DETERMINED TO BE USER TECHNIQUE. WE ARE CONTINUING OUR MONITORING OF SIMILAR COMPLAINTS AND APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    THE DISTAL 2-3CM OF THE 10F VASCULAR SHEATH WAS SHEARED FREE/PARTIALLY FREE WHILE THE PHYSICIAN WAS ADVANCING THE GUIDING CANNULA OVER A WIRE INTO A SMALL ACCESSORY HEPATIC VEIN. THE GUIDING CANNULA WAS REMOVED AND A SNARE WAS USED TO SNARE THE PARTIALLY FREE DISTAL PORTION. THE SNARE WAS SUCCESSFUL, BUT THE SHEATH BEGAN TO UNWIND AND THE DISTAL RADIOPAQUE BAND BECAME FREE AND EMBOLIZED TO THE AZYGOUS VEIN. ADDITIONAL ATTEMPTS WERE MADE TO RETRIEVE IT, BUT WERE UNSUCCESSFUL AND IT WAS LEFT IN PLACE. THE PHYSICIAN DID NOT FEEL IT QUALIFIED AS A SENTINEL EVENT, SO NOTHING WAS REPORTED, BUT RISK MANAGEMENT WAS CONTACTED. THERE ARE IMAGES OF THE EVENT, BUT THE HOSPITAL WOULD NOT ALLOW THEM TO BE COPIED FOR THE REPRESENTATIVE AS THE FAMILY WOULD NEED TO FIRST BE NOTIFIED AND APPROVED. MEDWATCH REPORT AS RECEIVED ON (B)(4) 2010: DURING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTS) PROCEDURE, THE SHEATH FRAYED AND BECAME LODGED IN A VEIN IN THE PT'S CHEST. CHEST X-RAY INDICATES FOREIGN BODY. TINY RING-LIKE OPACITY PROJECTED OVER THE RIGHT SIDE OF THE MEDIASTINUM. PT OUTCOME IS UNK AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK, INC. NA 2476262

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention