BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APD ALL PURPOSE DRAINAGE CATHETER SET GLIDEX

    MDR report key: 1024350 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00972
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETERAL STENT PLACEMENT PROCEDURE, THE STABILIZER JAMMED INTO THE END OF THE STENT AND IT WAS NOT POSSIBLE TO REMOVE THE STABILIZER WITHOUT DRAGGING THE STENT OUT WITH IT. AFTER DRAGGING THE STENT OUT, THE STAFF OPENED ANOTHER PACK AND USED THE STABILIZER FROM THAT PACK TO TRY AND DEPLOY THE FIRST STENT. THE NURSE REPORTED THAT IN THE ATTEMPT TO PLACE THE STENT WITH THE NEW STABILIZER, THE STENT AND STABILIZER CAME APART AND THE STENT MANAGED TO FORM A PIG TAIL THAT FELL INTO PLACE IN THE RENAL PELVIS. THE STENT WAS THEREFORE DEPLOYED AND IS NOT AVAILABLE FOR RETURN AND THE ORIGINAL STABILIZER WAS NOT RETAINED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PT IS REPORTED AS STABLE AND THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APD ALL PURPOSE DRAINAGE CATHETER SET GLIDEX FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M001245731 9487941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention