BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 2202992 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03225
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETERAL STENTING TREATMENT PROCEDURE, A TIP DETACHMENT OCCURRED. THE PERCUFLEX URETERAL STENT WAS PLACED IN THE PATIENT AND THE SUTURE WAS PULLED TO FORM THE PIGTAIL. FLUOROSCOPY SHOWED PART OF THE STENT HAD DETACHED AND WAS FREE IN THE KIDNEY. THE STENT CONTINUED TO DRAIN PROPERLY. THE RADIOLOGIST FELT THAT THE STENT FRAGMENT COULD BE REMOVED THROUGH THE EXISTING PORT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA M001245530 11789477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention