BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1213741 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05434
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND THAT THERE WERE SEVERAL KINKS ON THE BLUE SHEATH AND THAT THE WHITE HEAT SHRINK WAS JAMMED INTO THE BLUE SHEATH. PART OF THE CONE IS PEELED OFF THE CORE WIRE. THE CONE, DISTAL BALL AND DISTAL STOP ARE DETACHED FROM THE DEVICE AND IT IS NOT POSSIBLE TO OPEN AND CLOSE THE DEVICE. THE DAMAGE TO THE RETURNED COMPLAINT SAMPLE IS CONSISTENT WITH THE USE OF EXCESSIVE FORCE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS DETERMINED TO BE HANDLING DAMAGE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE RETURNED DEVICE ANALYSIS REVIEWED. IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE CONE WOULD NOT FORM. WHILE PREPARING A STONE CONE 3 FRENCH 7MM CONE FOR USE IN THE PROCEDURE, THE DEVICE WAS TESTED OUTSIDE THE PATIENT'S BODY AND IT WAS NOTICED THAT THE CONE WOULD NOT FORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE". THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE CONE WAS DETACHED FROM THE DEVICE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL FGO - DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC M0063903100 0000605982

    Patients

    Seq Age Sex Outcome Treatment
    1