BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 3250047 · Received July 19, 2013

    Report

    Report Number
    3008492462-2013-00021
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 19, 2013
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    NEU
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION; THEREFORE, A DEFINITIVE CONCLUSION COULD NOT BE REACHED REGARDING THIS SPECIFIC EVENT. BASED ON OUR KNOWLEDGE OF THE DEVICE DESIGN AND ITS PRESCRIBED USE, WE HAVE DEVELOPED A COMPREHENSIVE RISK MANAGEMENT FILE ASSOCIATED WITH OUR MAMMOMARK PRODUCT PORTFOLIO. THE MOST LIKELY SCENARIO IS THAT THE USER REMOVED THE MARKER APPLICATOR SEPARATELY FROM THE BIOPSY PROBE. TIP SHEAR HAS BEEN IDENTIFIED AS A POTENTIAL RISK WHENEVER THE APPLICATOR SHAFT IS REMOVED THROUGH THE BIOPSY PROBE. OUR MAMMOTOME VACUUM ASSISTED BIOPSY PROBES CONTAIN EXTREMELY SHARP EDGES ALONG THE APERTURE OPENING TO EFFECTIVELY EXCISE TISSUE. REMOVING THE APPLICATOR SHAFT CREATES THE POSSIBILITY OF THE APPLICATOR CATCHING ON ONE OF THESE EDGES AND SHEARING. AS MITIGATION STEP TO ADDRESS THIS RISK, WE PROVIDE CONTRAINDICATION LANGUAGE AND INSTRUCTION WITHIN THE INSTRUCTION FOR USE: WARNING: FAILURE TO ALIGN THE MAMMOMARK APPLICATOR AS SPECIFIED MAY RESULT IN IMPROPER DEPLOYMENT OF THE COLLAGEN PLUG AND POSSIBLE TIP SHEAR. INSTRUCTION #10: REMOVE THE MAMMOMARK APPLICATOR AND THE MAMMOTOME BIOPSY PROBE TOGETHER AS A SINGLE UNIT FROM THE SITE AND OBTAIN IMAGES TO CONFIRM MARKER PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP DURING A BREAST BIOPSY PROCEDURE, THE USER DEPLOYED THE DEVICE WITH NO DIFFICULTIES NOTED. WHEN REMOVING THE DEVICE FROM THE BIOPSY PROBE, THE TIP OF THE APPLICATOR SHEARED OFF AND WAS LEFT IN THE PT. AT THIS TIME, THERE ARE NO PLANS TO REMOVE THE TIP AND PT IS DOING WELL WITH NO CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339046 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER NEU DEVICOR MEDICAL PRODUCTS INC. MAM3001 F11207104D1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK