BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR UROLOGICAL GUIDEWIRE

    MDR report key: 1171353 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04643
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PREPARING FOR AN UNSPECIFIED UROLOGICAL PROCEDURE THE GUIDE WIRE WAS KINKED. THE TARGET LESION WAS AN UNSPECIFIED AREA WITHIN THE "URINARY DUCT". A SENSOR .035 3CM GUIDE WIRE HAD BEEN SELECTED FOR USE. DURING PREPARATION, THE OUTER COATING FOR USE. DURING PREPARATION, THE OUTER COATING OF THE GUIDE WIRE WAS FOUND TO BE "BENT" AT ABOUT 14 CM FROM THE DISTAL END. "NO EXCESS FORCE" HAD BEEN APPLIED TO THE DEVICE. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR UROLOGICAL GUIDEWIRE EZB BOSTON SCIENTIFIC M0066703051 11755566

    Patients

    Seq Age Sex Outcome Treatment
    1