BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, OPEN END URETERAL AXXCESS

    MDR report key: 2141588 · Received June 10, 2011

    Report

    Report Number
    2141588
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PREOPERATIVE DIAGNOSIS WAS RIGHT MID URETERAL STONE WITH SEVERE COLIC. DURING CYSTOSCOPY WITH A RETROGRADE STENT PLACEMENT, THE URETERAL ACCESS CATHETER BROKE INTO THREE PIECES, ALL OF WHICH WERE RECOVERED FROM THE BLADDER. A NEW ACCESS CATHETER WAS GIVEN TO THE STERILE FIELD AND THE CASE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, OPEN END URETERAL AXXCESS OPEN END URETERAL CATHETER EYB BOSTON SCIENTIFIC * 14226948

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR