BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 2150307 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02154
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE COMPLAINANT REPORTED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD AND SIMILAR COMPLAINT FOR THE PROLIEVE CATHETER LOT # 615125 CONTAINED IN THE PROLIEVE THERMODILITATION KIT WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION KIT WAS USED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). ACCORDING TO THE COMPLAINANT, DUE THE PROCEDURE, THE PROSTATIC DILATION BALLOON BEGAN TO LEAK. THE PHYSICIAN REPLACED THE CATHETER AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK