BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 1932700 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05157
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS USED IN A CYSTOSCOPY PROCEDURE WITH BILATERAL URETEROSCOPY, STONE LASERING AND STONE BASKETING ACCORDING TO THE COMPLAINANT, THE DEVICE BROKE WHEN THE STRING WAS PULLED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M0061752520 13368563

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR