BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 1893660 · Received November 2, 2010

    Report

    Report Number
    1825146-2010-00049
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 2, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE COMPLAINT DEVICE NOT BEING RETURNED, A PROPER EVAL COULD NOT BE PERFORMED. THE CUSTOMER INDICATED THE STENT SEPARATED DUE TO SEVERE CALCIFICATION AT THE VERY DISTAL END. BECAUSE, STENT MATERIAL CAN REACT IN UNEXPECTED WAYS DEPENDING ON THE PT'S INDIVIDUAL BODY CHEMISTRY, MEDICATIONS ADMINISTERED, AS WELL AS DEGRADING WITH EXPOSURE TO UV LIGHT, WE ARE UNABLE TO ASCERTAIN WITH ANY CERTAINTY THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO REMOVE A STENT THAT WAS PLACED IN THE RIGHT URETER OF A MALE PT (B)(6) ON (B)(6) 2010, THE STENT SEPARATED DUE TO SEVERE CALCIFICATION AT THE VERY DISTAL END. IT WAS LODGED IN THE PT DUE TO SAID CALCIFICATION. IN AN ATTEMPT TO BREAK UP THE CALCIFICATION, THEY HAD TO LASER IT OUT IN ORDER TO GET THE OTHER PART OF THE STENT THAT BROKE OFF IN THE PT. THEY CHECKED BY X-RAY TO MAKE SURE THE SEPARATED SEGMENT WAS RETRIEVED, AND IT IS BELIEVED THEY WERE FINALLY ABLE TO RETRIEVE EVERYTHING. HOWEVER, IT WAS MENTIONED THIS HAD NEVER HAPPENED BEFORE, AND THEY WERE VERY CONCERNED. PT IS DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA U1868124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention