BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER

    MDR report key: 7033742 · Received November 15, 2017

    Report

    Report Number
    1820334-2017-04082
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    May 20, 2016
    Report Date
    November 15, 2017
    Manufacturer
    COOK INC
    Product Code
    GCA
    UDI-DI
    00827002119567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #/LOT # RPN: ULT10.2-38-50-P-RING-25.5-MEH-RH. 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 THE DOCTOR WAS UNABLE TO REMOVE THE STIFFENER AFTER PLACEMENT. IT WAS REPLACED WITH ANOTHER DEVICE. IT WAS NOTED AFTER REMOVAL THAT THE STIFFENER WAS STRETCHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815102 ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY GCA COOK INC 00827002119567

    Patients

    Seq Age Sex Outcome Treatment
    1