BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX¿ PLUS

    MDR report key: 6801279 · Received August 17, 2017

    Report

    Report Number
    3005099803-2017-02290
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 19, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    UDI-DI
    08714729340003
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2017, AND WAS ATTEMPTED TO BE REMOVED DURING A REMOVAL CATHETER J PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE REMOVAL CATHETER J PROCEDURE, AN ATTEMPT TO REMOVE THE PERCUFLEX¿ PLUS URETERAL STENT WAS PERFORMED; HOWEVER, DISTAL DOUBLE J FAILED TO UNCOIL LEAVING THE STENT STUCK IN THE DISTAL END OF THE URETER. THE STENT WAS CUT USING A HOLMIUM LASER AND THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A TWO HOUR SURGERY. ADDITIONALLY, IT WAS REPORTED THAT TRAUMA WAS NOTED ON THE URETER INCREASING THE SURGICAL RISK AND THE POSSIBLE COMPLICATIONS. DURING THE SURGERY THE PATIENT HAD TRAUMA IN THE URETER DUE TO HANDLING, BUT THE PATIENT IS STABLE NOW, WITHOUT INJURY, AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581362 PERCUFLEX¿ PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006175262010 19998781 08714729340003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention