BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX PLUS URETERAL STENT

    MDR report key: 1532878 · Received November 3, 2009

    Report

    Report Number
    3005099803-2009-05194
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    September 26, 2009
    Report Date
    October 9, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, AN ANALYSIS HAS NOT BEEN PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, A PERCUFLEX PLUS URETERAL STENT WAS GOING TO BE USED IN A PLACEMENT CATHETER DOUBLE-J BY URETEROSCOPY PROCEDURE ON A MALE PATIENT (B)(6). ACCORDING TO THE COMPLAINANT, WHEN THE PACKAGE WAS OPENED, THE NURSE NOTICED ONE OF THE LOOPS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A SECOND PERCUFLEX PLUS URETERAL STENT. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX PLUS URETERAL STENT FGE BOSTON SCIENTIFIC CORP M0061752620 12799707

    Patients

    Seq Age Sex Outcome Treatment
    1