BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 2183140 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02541
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A STENT PLACEMENT PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS UNABLE TO BE ADVANCED INSIDE THE PATIENT PROPERLY. THE STENT WAS WITHDRAWN NORMALLY FROM THE PATIENT, AND A TEAR WAS NOTICED AT THE SIDE HOLE OF THE PROXIMAL END OF THE STENT. PRIOR TO USE, THE SUTURE HAD BEEN REMOVED, AND NO ANOMALY WAS NOTICED DURING INITIAL INSPECTION OF THE DEVICE. THE PATIENT IS REPORTEDLY OVER 18 YEARS OLD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "GOOD."

    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 M006175262080

    Patients

    Seq Age Sex Outcome Treatment
    1