BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET

    MDR report key: 8167668 · Received December 15, 2018

    Report

    Report Number
    1820334-2018-03759
    Event Type
    Malfunction
    Date Received
    December 15, 2018
    Report Date
    December 15, 2018
    Manufacturer
    COOK INC
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) THE SHEATH OF THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET CAME APART AT THE HUB AND WAS SHOWING ITS BRAIDING. ANOTHER DEVICE WAS USED FOR THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER NOTED THAT SOME OF THE SHEATH MATERIAL HAD SEPARATED AND THE COIL WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006725 ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1