BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000037-1999-00026

    MDR report key: 258121 · Received December 29, 1999

    Report

    Report Number
    6000037-1999-00026
    Event Type
    Injury
    Date Received
    December 29, 1999
    Date of Event
    September 23, 1999
    Report Date
    December 10, 1999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROXIMAL SEGMENT OF THIS URETERAL STENT BROKE AND DETACHED IN THE PT'S RENAL PELVIS FOLLOWING SUCCESSFUL STENT PLACEMENT. ATTEMPTS TO RETRIEVE THE DETACHED SEGMENT WERE UNSUCCESSFUL AT THAT TIME. ONE WEEK POST-PLACEMENT, THE PT UNDERWENT RETRIEVAL OF THE STENT AND STENT FRAGMENT VIA A CYSTOURETHROSCOPY. ANOTHER STENT WAS PLACED AT THAT TIME. TWO DAYS POST-PLACEMENT, THE PT WAS DISCHARGED. THE FOLLOWING DAY, THE PT UNDERWENT STENT REMOVAL AT ANOTHER USER FACILITY. TO DATE, THE DEVICE HAS NOT BEEN REC'D BY THIS MFR. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. NUMEROUS ATTEMPTS TO OBTAIN FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL. WITHOUT FURTHER DETAILS AND WITHOUT EVALUATING THE DEVICE, THE CO IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention