BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISCELLANEOUS

    MDR report key: 1252406 · Received December 4, 2008

    Report

    Report Number
    1825146-2008-00038
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 28, 2008
    Manufacturer
    COOK UROLOGICAL INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WERE THE EVENT OCCURRED IS NOT WILLING TO RETURN THE STENT FOR EVALUATION. HOWEVER, OUR SALES REPRESENTATIVE IN THE AREA WAS ALLOWED TO TAKE PHOTOGRAPHS OF THE REMOVED STENT; THE STENT WAS NOTED TO BE IN THREE SEGMENTS. THE FACILITY WHERE THE STENT WAS PLACED AND REMOVED INDICATED THE ONLY STENT INFORMATION IN THE PATIENTS CHART WAS FOR A 133624 WHICH IS A BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT. THE PHOTOGRAPHS THAT WERE RECEIVED INDICATED THE STENT IS NOT BLACK IN COLOR, THEREFORE NOT A BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT. THE INFORMATION THE SALES REPRESENTATIVE HAS BEEN ABLE TO PROVIDE IS THAT IT IS POSSIBLY AN 039XXX STENT, HOWEVER, NO ADDITIONAL DETAILS ON THE EXACT PART NUMBER HAVE BEEN PROVIDED. THE SALES REPRESENTATIVE MET WITH THE PATIENT'S PRIMARY PHYSICIAN REGARDING THE SOF-FLEX STENT FAILURE. HE WS AWAY DURING THE TIME WHEN THE STENT WAS INITIALLY PLACED AND LATER REMOVED. THE ATTENDING PHYSICIAN WAS DOING A LOCUM AT THIS TIME FOR THE PATIENT'S PRIMARY PHYSICIAN. THE PRIMARY PHYSICIAN WAS UNABLE TO RECALL THIS PATIENT OR NOTE HIS CURRENT CONDITION. ANECDOTALLY, THE UROLOGY CHARGE NURSE REMEMBERS THAT THE INITIAL PLACEMENT OF THE BLACK SILICONE STENT WENT WITH SOME DIFFICULTY DUE TO THE PATIENT'S SOMEWHAT TORTUOUS URETER, SO THE FIRMER SOFT-FLEX WAS THEN PLACED WITH EASE. THE STORAGE CONDITIONS OF THE FACILITY WERE ALSO VIEWED AND NOTED TO BE DIMLY LIT AND COOK STENTS STORED ON THE BOTTOM SHELF OF THE CART. AS STATED IN THE INFORMATION FOR USE BOOKLET, "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE." UNABLE TO DETERMINE WHAT WAS CAUSED THE STENT TO SEPARATE. CURRENTLY CONTINUING TO INVESTIGATE THIS INCIDENT AS WELL AS REQUESTED ADDITIONAL INFORMATION. AN UPDATE WILL BE SENT AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT PEE'D OUT THE DISTAL PORTION OF THE STENT, HAS A FRAGMENT IN THE BLADDER AND THE REST IS IN PLACE WITH THE PROXIMAL PORTION OF THE STENT IN THE UPPER URETER AND KIDNEY. A PORTION OF THE STENT WAS RETRIEVED FROM THE PATIENTS BLADDER AND A SECOND PORTION REMOVED FROM THE LEFT URETER AND RENAL PELVIS. THE PATIENT HAD A RENAL ULTRASOUND AND AN XRAY OF HIS KIDNEYS, URETERS AND BLADDER TO DETERMINE STENT POSITION FOLLOWING THE PRESENTATION IN OFFICE. (PASSED A SMALL PORTION OF STENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MISCELLANEOUS FAD STENT, URETERAL FAD COOK UROLOGICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR