BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 2872522 · Received December 12, 2012

    Report

    Report Number
    3008492462-2012-00049
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FROM SALES REP: DURING THE PROCEDURE, THE PHYSICIAN FELT THE DEVICE WAS DIFFICULT TO DEPLOY. THE DEVICE EXTENDED OUT OF THE APERTURE AND WASN'T ABLE TO BE PULLED BACK INTO THE SHAFT. THE TIP SHEAR OCCURRED AT THIS TIME. THERE WAS A SEPARATE PROCEDURE TO RETRIEVE THE TIP THAT OCCURRED AROUND (B)(6) 2012. THE PT IS DOING WELL AT THIS TIME. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR INSPECTION AND EVAL; 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 SHIFT 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 A MITIGATION STEP TO ADDRESS THIS RISK, WE PROVIDE CONTRAINDICATION LANGUAGE AND INSTRUCTION WITHIN THE INSTRUCTIONS 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 THAT THE DEVICE WAS NOT DEPLOYING AND A TIP SHEAR INCIDENT OCCURRED. THE TIP WAS LEFT IN THE PT AND A SEPARATE PROCEDURE WAS PERFORMED TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER KNW DEVICOR MEDICAL PRODUCTS INC. MAM3008 F11229503D1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK