BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 2854547 · Received November 29, 2012

    Report

    Report Number
    3008492462-2012-00048
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    NEU
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE: THE USER FELT RESISTANCE WHEN TRYING TO DEPLOY THE MARKER AND ROTATED THE PROBE AND MARKER TO THE 6 O'CLOCK POSITION TO REMOVE. THE USER MAY HAVE ROTATED THE PROBE SEPARATELY FROM THE MARKER BASED ON SALES REP DISCUSSION WITH THE ACCOUNT POTENTIALLY CAUSING THE TIP TO SHEAR. THE TIP WAS LEFT IN THE PATIENT AND THE LESION WAS BENIGN. THE PATIENT HAD A FOLLOW UP PROCEDURE PERFORMED IN THE OFFICE TO REMOVE THE TIP FROM THE SUPERFICIAL LESION. THE DEVICE IS NOT BEING RETURNED FOR ANALYSIS AT THIS TIME. A BIOCOMPATIBILITY LETTER WAS SENT TO USER, AS REQUESTED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR INSPECTION AND EVALUATION; 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 OR ROTATED 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 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 TO 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 THE USER SHEARED OFF THE TIP OF THE DEVICE INTO THE BIOPSY SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK