BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINESSE ULTRA BIOPSY PROBE

    MDR report key: 5006909 · Received July 28, 2015

    Report

    Report Number
    2020394-2015-01189
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    January 29, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K093068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER CLINICAL REVIEW OF THIS EVENT WITH BARD'S MEDICAL DEPARTMENT, THIS EVENT WAS REASSESSED AND DETERMINED TO BE MDR REPORTABLE AS A SERIOUS INJURY PURSUANT TO 21 CFR PART 803. A MANUFACTURING REVIEW WAS PERFORMED. THE LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION IS INCONCLUSIVE, AS THE PROBE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. THE CURRENT FINESSE PROBE IFU STATES: BEGIN TISSUE SAMPLING BY PRESSING THE "SAMPLE" BUTTON. THE SAMPLING PROCESS PROCEEDS AUTOMATICALLY: A VACUUM IS CREATED, THE OUTER CANNULA OF THE PROBE IS AUTOMATICALLY RETRACTED, TISSUE IS DRAWN BY VACUUM INTO THE SAMPLING CHAMBER AND THE OUTER CANNULA IS RELEASED CUTTING THE TISSUE. THE TISSUE SAMPLE IS THEN TRANSPORTED TO THE SAMPLE CONTAINER. DURING THIS PROCESS THE "SAMPLE" INDICATOR LIGHT CONTINUOUSLY ILLUMINATES ORANGE AND THE MOTOR WILL BE AUDIBLE. THE SAMPLE CONTAINER ILLUMINATES TO AID IN VISUALIZING THE TISSUE SAMPLE. AFTER THE TISSUE SAMPLE IS DEPOSITED INTO THE SAMPLE CONTAINER THE SYSTEM RESETS TO ACQUIRE ANOTHER SAMPLE IF DESIRED. NOTE: DO NOT PRESS ON THE SAMPLE CONTAINER OR REMOVE THE SAMPLE CONTAINER WHILE ACQUIRING TISSUE SAMPLES 6. TO ACQUIRE MULTIPLE SAMPLES, REPEAT STEP 5 ABOVE. NOTE: COLLECTING MULTIPLE TISSUE SAMPLES MAY HELP MINIMIZE THE RISK OF A FALSE NEGATIVE BIOPSY. REMOVE THE TISSUE SAMPLES FROM THE SAMPLE CONTAINER BY TWISTING THE LID COUNTER CLOCKWISE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED CORE BREAST BIOPSY, AFTER TWO SAMPLE ACQUISITIONS, NO TISSUE SAMPLES WERE COLLECTED WITHIN THE SAMPLE CUP. THE PROCEDURE WAS RE-SCHEDULED ON ANOTHER DAY AND COMPLETED BY USING A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491180 FINESSE ULTRA BIOPSY PROBE KNW BARD PERIPHERAL VASCULAR, INC. 91001905

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R